Trials (Netherlands Cancer Institute - Antoni van Leeuwenhoek)
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NCTID: NCT04614103
Title: Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer Study Summary: This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic non-small-cell lung cancer Sponsor: Iovance Biotherapeutics, Inc. Intervention: LN-145 Start Date: 2021-05-07 Last Updated: 2023-10-10 Number of Patients: 170 Recruitment Status: RECRUITING Condition: Metastatic Non Small Cell Lung Cancer
NCTID: NCT03396445
Title: Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001) Study Summary: The purpose of this study is to assess the safety and pharmacokinetics of boserolimab (MK-5890) when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of boserolimab monotherapy or boserolimab plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of boserolimab when administered with pembrolizumab, pemetrexed and carboplatin in adults with non squamous non-small cell lung cancer (NSCLC) and boserolimab when administered with pembrolizumab and nab-paclitaxel in adults with triple-negative breast cancer (TNBC) will also be assessed. Sponsor: Merck Sharp & Dohme LLC Intervention: Boserolimab Start Date: 2018-02-18 Last Updated: 2023-04-11 Number of Patients: 202 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Pharmacokinetics
NCTID: NCT03595059
Title: A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors Study Summary: An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone and in combination with paclitaxel or docetaxel. In Part 1 (dose escalation), participants will receive escalating doses of ABBV-155 monotherapy (Part 1a) or ABBV-155 in combination with paclitaxel or docetaxel (Part 1b). In Part 2 (dose expansion), participants will receive ABBV-155 monotherapy or in combination therapy. The ABBV-155 monotherapy cohort will enroll participants with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the ABBV-155 plus a taxane (paclitaxel or docetaxel) combination cohort will enroll participants with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b). Sponsor: AbbVie Intervention: ABBV-155 Start Date: 2018-07-13 Last Updated: 2023-10-30 Number of Patients: 169 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT00052754
Title: Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma Study Summary: RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of synovial sarcoma. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: gefitinib Start Date: 2002-10 Last Updated: 2012-09-24 Number of Patients: 48 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT02450656
Title: Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer Study Summary: This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in combination with selumetinib in KRASm NSCLC; and PART B - a randomized phase II study investigating the progression free survival and safety of selumetinib/afatinib combination therapy compared to standard of care chemotherapy in KRASm NSCLC. Sponsor: The Netherlands Cancer Institute Intervention: Afatinib Start Date: 2015-06 Last Updated: 2018-08-27 Number of Patients: 320 Recruitment Status: UNKNOWN Condition: Colorectal Neoplasms
NCTID: NCT05084456
Title: Oral Docetaxel in Patients With Normal or Impaired Liver Function Study Summary: This is an open label, single centre pharmacological and safety study to define the safety and pharmacokinetics of ModraDoc006/r in a weekly dosing schedule in patients with impaired liver function who might have benefit from a weekly docetaxel regime. The safety of ModraDoc006 in combination with ritonavir for the patients with mild and moderate impaired liver function will be evaluated with a dose escalation design. Sponsor: Modra Pharmaceuticals Intervention: ModraDoc006/r Start Date: 2017-07 Last Updated: 2021-10-19 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Solid Tumor, Adult
NCTID: NCT05400954
Title: Association of Silicone Breast Implants With Overall Wellbeingand Auto-immune Diseases Study Summary: Background: Implant-based breast reconstructions contribute considerably to the quality of life of breast cancer patients. A knowledge gap exists concerning the potential role of breast implants in the development of so called ‘breast implant illness’ and autoimmune diseases in breast cancer survivors with a silicone breast implant-based reconstruction. Breast implant illness is a constellation of non-specific symptoms reported by a small group of women with silicone breast implants. Methods/Design: The Areola study is a multi-centre historic cohort study with prospective follow-up aiming to assess the risk of ‘breast implant illness’ and autoimmune diseases in female breast cancer survivors with and without silicone breast implants. The cohort consists of breast cancer survivors who received surgical treatment with silicone implant-based reconstruction in six major hospitals across the Netherlands in the period between 2000 and 2015. As comparison group, a frequency-matched sample of breast cancer survivors without breast implants will be selected. An additional group of women who received breast augmentation surgery in the same years will be selected to compare their characteristics and health outcomes with those of breast cancer patients with implants. All women still alive will be invited to complete a web-based questionnaire covering various health related topics. The entire cohort including deceased women will be linked to the population based computerized databases of Statistics Netherlands. These databases include a registry of diagnostic codes, a pharmacotherapeutic prescriptions registry and a cause-of-death registry in which diagnoses of autoimmune diseases will be identified. Outcomes of interest are the prevalence and incidence of BII and the prevalence and incidence of autoimmune diseases. In addition, risk factors for the development of BII and autoimmune disorders will be assessed among women with implants. Discussion: The Areola study will contribute to the availability of reliable information on the risks of breast implant illness and autoimmune diseases in Dutch breast cancer survivors with silicone breast implants. This will inform breast cancer survivors and aid future breast cancer patients and their treating physicians to make informed decisions about reconstructive strategies after mastectomy. Keywords: Silicone breast implants, Breast reconstruction, Breast cancer, Breast Implant Illness, Autoimmune disease Sponsor: The Netherlands Cancer Institute Intervention: Breast reconstruction with silicone breast implant Start Date: 2022-07-01 Last Updated: 2023-04-28 Number of Patients: 15000 Recruitment Status: ENROLLING_BY_INVITATION Condition: Breast Cancer
NCTID: NCT00028886
Title: Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). It is not yet known whether chemotherapy followed by peripheral blood stem cell transplant is more effective with or without thalidomide in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with thalidomide to see how well it works compared with giving combination chemotherapy without thalidomide in treating patients with multiple myeloma. Sponsor: Commissie Voor Klinisch Toegepast Onderzoek Intervention: filgrastim Start Date: 2001-03 Last Updated: 2013-09-17 Number of Patients: 450 Recruitment Status: UNKNOWN Condition: Multiple Myeloma and Plasma Cell Neoplasm
NCTID: NCT01606566
Title: A Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin for Recurrent Head and Neck Cancer. Study Summary: The purpose of this study is to evaluate the efficacy and safety of Amphinex induced PCI of bleomycin (‘PC-A11’) with superficial and/or interstitial laser light application in patients with recurrent SCCHN. Sponsor: PCI Biotech AS Intervention: Amphinex induced PCI of bleomycin Start Date: 2012-04 Last Updated: 2022-02-18 Number of Patients: 26 Recruitment Status: TERMINATED Condition: Recurrent Head and Neck Cancer
NCTID: NCT02159066
Title: LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma Study Summary: The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in combination with targeted agents after progression on LGX818/MEK162 combination therapy, as well as the safety and tolerability of the novel triple combinations. Sponsor: Pfizer Intervention: LGX818 Start Date: 2014-07-23 Last Updated: 2023-04-26 Number of Patients: 160 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT03590119
Title: Intra-arterial Lutetium-177-dotatate for Treatment of Patients With Neuro-endocrine Tumor Liver Metastases Study Summary: The objective is to investigate the impact of intra-arterial administration of 177Lu-dotatate on the intrahepatic biodistribution in patients with NET liver metastases. Our primary objective is to evaluate if there is a difference in post-treatment tumor-to-non-tumor (T
) activity concentration ratio on SPECT/CT between the intra-arterial treated liver lobe and the intravenous treated liver lobe.
Sponsor: Marnix Lam Intervention: Lutetium Lu 177-DOTATATE Start Date: 2018-08-01 Last Updated: 2022-11-08 Number of Patients: 26 Recruitment Status: COMPLETED Condition: Neuroendocrine Tumors
NCTID: NCT00676507
Title: Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy Study Summary: Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than a placebo as maintenance therapy in treatment of subjects with non-small cell lung cancer. Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works compared with a placebo in treating subjects with stage III or stage IV non-small cell lung cancer. Sponsor: NovaRx Corporation Intervention: Lucanix™ Start Date: 2008-07 Last Updated: 2015-05-08 Number of Patients: 532 Recruitment Status: COMPLETED Condition: Lung Neoplasm
NCTID: NCT02810743
Title: Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer Study Summary: Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue. Sponsor: The Netherlands Cancer Institute Intervention: ddAC-CP-Olaparib Start Date: 2017-01-25 Last Updated: 2023-11-24 Number of Patients: 174 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05401786
Title: Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC Study Summary: Still many advanced non-small cell lung cancer (NSCLC) patients do not benefit from PD-(L)1 inhibition or will eventually develop progression through secondary resistance. Inhibition of CTLA-4, application of radiotherapy together with PD-1 inhibition showed synergistic effects and is deemed safe. Sponsor: The Netherlands Cancer Institute Intervention: Ipilimumab Start Date: 2023-01-03 Last Updated: 2023-01-11 Number of Patients: 54 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03834519
Title: Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5’-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: # Overall Survival (OS) and # Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-02 Last Updated: 2023-11-07 Number of Patients: 793 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT00263822
Title: Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer Study Summary: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether erlotinib is more effective than observation after first-line chemotherapy in treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer, peritoneal cancer, or fallopian tube cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: erlotinib hydrochloride Start Date: 2005-09 Last Updated: 2013-08-27 Number of Patients: 835 Recruitment Status: COMPLETED Condition: Fallopian Tube Cancer
NCTID: NCT03465722
Title: (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST Study Summary: This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs. Sponsor: Blueprint Medicines Corporation Intervention: avapritinib Start Date: 2018-03-26 Last Updated: 2022-10-06 Number of Patients: 476 Recruitment Status: COMPLETED Condition: GIST
NCTID: NCT04211337
Title: A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer Study Summary: The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib. Sponsor: Loxo Oncology, Inc. Intervention: Selpercatinib Start Date: 2020-02-11 Last Updated: 2023-10-30 Number of Patients: 291 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Medullary Thyroid Cancer
NCTID: NCT04895722
Title: Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) Study Summary: The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-06-25 Last Updated: 2023-11-24 Number of Patients: 320 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT00659022
Title: Neo-adjuvant Therapy and the Effect on Synchronous Metastatic Growth Study Summary: Study Hypothesis • As well as in animal models as in patients with colorectal cancer resection of the primary tumor resulted in increase in vascular density, metabolism and secondary tumor growth of the distant metastases. These data strongly suggest an inhibitory effect of the primary tumor on the outgrowth of its metastases. In this study we investigate whether pre-operative treatment with the anti-angiogenic agent bevacizumab and/or chemotherapy before resection of the primary colorectal tumor shifts the balance between angiogenic and anti-angiogenic factors in favor of the anti-angiogenic factors and results in reduced growth of the liver metastases. Eligibility * Histological proven colorectal cancer without signs of bowel obstruction or bleeding * Synchronous liver metastases * WHO performance status 0-1 Treatment * Arm A: immediate surgery of the primary colorectal tumor, no neoadjuvant therapy * Arm B: neoadjuvant treatment with bevacizumab during 7 weeks prior to surgery of the colorectal primary * Arm C: neoadjuvant treatment with CAPOX during 7 weeks prior to surgery of the colorectal primary * Arm D: neoadjuvant treatment with bevacizumab and CAPOX during 7 weeks prior to surgery of the colorectal primary Primary endpoint Difference in response of liver metastases to resection of the primary tumor between the experimental groups and the control group, as determined by histopathological scoring of vascular density, apoptotic and mitotic index and by measurement of the metabolic activity of liver metastases by FDG-PET and SUV measurements. Secondary endpoints Toxicity of neo-adjuvant treatment Complications of surgery Sponsor: Radboud University Medical Center Intervention: immediate surgery (resection of primary colorectal tumor) Start Date: 2008-07 Last Updated: 2011-09-12 Number of Patients: 60 Recruitment Status: UNKNOWN Condition: Colorectal Neoplasms
NCTID: NCT05208047
Title: (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors Study Summary: This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. Sponsor: Cogent Biosciences, Inc. Intervention: CGT9486 plus sunitinib Start Date: 2022-04-14 Last Updated: 2023-11-28 Number of Patients: 426 Recruitment Status: RECRUITING Condition: Advanced Gastrointestinal Stromal Tumors
NCTID: NCT03271047
Title: Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation Study Summary: This is a multicenter, open-label, Phase 1B/2 study to evaluate the safety and assess the preliminary anti-tumor activity of binimetinib administered in combination with nivolumab or nivolumab + ipilimumab in adult patients with advanced metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) disease and presence of a RAS mutation that have received at least one prior line of therapy and no more than 2 prior lines of therapy. The study contains a Phase 1b period to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) and schedule of binimetinib followed by a randomized Phase 2 period to assess the efficacy of the combinations. Sponsor: Pfizer Intervention: binimetinib Start Date: 2017-10-18 Last Updated: 2022-01-04 Number of Patients: 75 Recruitment Status: COMPLETED Condition: MSS
NCTID: NCT04989387
Title: Study of INCA 0186 in Subjects With Advanced Solid Tumors Study Summary: This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy. Sponsor: Incyte Corporation Intervention: INCA00186 Start Date: 2021-10-04 Last Updated: 2023-07-12 Number of Patients: 57 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT03037385
Title: Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors Study Summary: This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors. Sponsor: Hoffmann-La Roche Intervention: pralsetinib (BLU-667) Start Date: 2017-03-17 Last Updated: 2023-11-27 Number of Patients: 589 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: RET-altered Non Small Cell Lung Cancer
NCTID: NCT04196283
Title: A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Study Summary: The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Sponsor: AbbVie Intervention: ABBV-368 Start Date: 2020-01-22 Last Updated: 2023-02-27 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Advanced Solid Tumors Cancer
NCTID: NCT00004179
Title: Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: rituximab Start Date: 1999-05 Last Updated: 2021-02-15 Number of Patients: 475 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT03348150
Title: Gastrectomy + Cytoreductive Surgery + HIPEC for Gastric Cancer With Peritoneal Dissemination. Study Summary: A randomized controlled two-armed phase III trial for gastric cancer patients with peritoneal dissemination. Randomization between gastrectomy + cytoreductive surgery + HIPEC (experimental arm) and palliative systemic chemotherapy (standard arm). Sponsor: The Netherlands Cancer Institute Intervention: Cytoreductive surgery + Gastrecomy Start Date: 2017-10-01 Last Updated: 2022-02-15 Number of Patients: 182 Recruitment Status: RECRUITING Condition: Stomach Neoplasm
NCTID: NCT00783822
Title: Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients Study Summary: 5-10% of breast cancer patients carry a mutation in the BRCA1 or BRCA2 gene. Genetic counseling and DNA testing are usually offered to selected patients after primary treatment has been completed (e.g. the first year after diagnosis). For women with a mutation in one of the two breast-ovarian cancer syndrome genes, chances of a second breast cancer are high, and therefore a proportion of these women may opt for preventive measures in addition to their immediate breast cancer treatment. Contralateral prophylactic mastectomy significantly reduces this risk, and is associated with a reduction in mortality. Genetic counseling and testing for breast cancer typically takes approximately 4-6 months to complete. However, some hospitals and laboratories are now able to generate test results within 3 to 6 weeks. This technology of rapid genetic testing creates new opportunities for providing both women and their treating surgeons with information potentially relevant for deciding between available treatment options, including type of surgery and adjuvant therapy. The study will focus on newly diagnosed breast cancer patients who, prior to receiving treatment, are identified as having at least a 10% risk of carrying a mutation in the BRCA1 or BRCA2 genes. We will investigate whether women with a recent diagnosis of breast cancer make use of rapid genetic counseling when offered. Furthermore, we will investigate whether the process of genetic counseling (and subsequent DNA testing) has influence on the choice of treatment, and whether and how such rapid genetic counseling and testing (RGCT) affects levels of risk perception, cancer-related worries and distress, and decisional satisfaction. Sponsor: The Netherlands Cancer Institute Intervention: RGCT Start Date: 2008-11 Last Updated: 2012-11-09 Number of Patients: 265 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT05238922
Title: Study of INCB123667 in Subjects With Advanced Solid Tumors Study Summary: This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A. Sponsor: Incyte Corporation Intervention: INCB0123667 Start Date: 2022-07-05 Last Updated: 2023-11-03 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT01950871
Title: Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning Study Summary: The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS) analysis can be used to improve the detection of clinically significant prostate cancer (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice. Prostate HS is an ultrasound-based tissue characterization technology specifically developed to detect, visualize, and locate tissue suspected of harboring PCa. These suspicious tissues are displayed as red areas on an imaging monitor. Recently a new biopsy guidance tool has been developed that uses the results of the prostate HS analysis. The subjects that will participate in this study are all scheduled for a first biopsy of the prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS. This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis and new biopsy guidance tool. Sponsor: Advanced Medical Diagnostics s.a. Intervention: Prostate HistoScanning Start Date: 2013-10 Last Updated: 2015-01-05 Number of Patients: 80 Recruitment Status: TERMINATED Condition: Prostate Cancer
NCTID: NCT04626479
Title: Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) Study Summary: Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-12-16 Last Updated: 2023-11-24 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT03361865
Title: Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307) Study Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma. Sponsor: Incyte Corporation Intervention: Pembrolizumab Start Date: 2017-12-04 Last Updated: 2021-12-16 Number of Patients: 93 Recruitment Status: COMPLETED Condition: UC (Urothelial Cancer)
NCTID: NCT05050942
Title: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET Study Summary: The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029. Sponsor: Camurus AB Intervention: CAM2029 Start Date: 2021-10-22 Last Updated: 2023-10-06 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Gastro-enteropancreatic Neuroendocrine Tumor
NCTID: NCT00433589
Title: Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving chemotherapy and hormone therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether genetic testing is more effective than clinical assessment in determining the need for chemotherapy in treating breast cancer. PURPOSE: This randomized phase III trial is studying genetic testing to see how well it works compared with clinical assessment in determining the need for chemotherapy in women with breast cancer that is either node-negative or involves no more than 3 lymph nodes. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: anthracycline-based Start Date: 2007-02 Last Updated: 2022-11-17 Number of Patients: 6600 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03522142
Title: A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies Study Summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and INCB081776 in combination with INCMGA00012 (Part 2). Sponsor: Incyte Corporation Intervention: INCB081776 Start Date: 2018-08-27 Last Updated: 2023-07-19 Number of Patients: 84 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT02291289
Title: A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) Study Summary: This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years. Sponsor: Hoffmann-La Roche Intervention: Cetuximab Start Date: 2015-04-17 Last Updated: 2021-05-26 Number of Patients: 609 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02665416
Title: Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors Study Summary: This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic activity of Selicrelumab in combination with vanucizumab or bevacizumab in participants with metastatic solid tumors not amenable to standard treatment. Part I (dose escalation) is designed to establish the maximum tolerated dose (MTD) of Selicrelumab in this combination. Part II (expansion) is intended to characterize the safety and tolerability of Selicrelumab in combination with bevacizumab among indication-specific cohorts and to confirm the recommended dose. Sponsor: Hoffmann-La Roche Intervention: Selicrelumab Start Date: 2016-01-25 Last Updated: 2020-04-07 Number of Patients: 94 Recruitment Status: COMPLETED Condition: Advanced/Metastatic Solid Tumors
NCTID: NCT03835793
Title: Health After eaRly Menopause Due to Oophorectomy Study Summary: Risk-Reducing Salpingo-Oophorectomy (RRSO) at the age of 35 to 45 years is recommended for women with a high genetic risk for ovarian cancer. While this procedure decreases the risk of ovarian cancer by 80-96%, it also results in an immediate menopause. Current research on potential adverse effects of premenopausal risk-reducing salpingo-oophorectomy, such as increased risk of cardiovascular disease, compromised bone health, cognitive dysfunction and reduced quality of life, is limited, mostly due to short follow up. The investigators will conduct a multicenter cross-sectional study nested in a cohort of BRCA mutation carriers from 8 Dutch centers for hereditary cancer. Eligible participants are women who underwent RRSO before the age of 45. The participants will be frequency-matched on current age with women above the age of 55 without RRSO or with RRSO after the age of 55. Participants will complete an online questionnaire containing various questions about lifestyle, medical history, risk factors for cardiovascular disease, bone health, cognition and quality of life. Participants will be asked to visit one of the participating hospitals for a blood test, a cardiovascular assessment and a DEXA scan for determining bone mineral density. Afterwards participants will be requested to perform the online Amsterdam Cognition Scale. Sponsor: The Netherlands Cancer Institute Intervention: CAC-score Start Date: 2019-02-11 Last Updated: 2020-09-14 Number of Patients: 750 Recruitment Status: UNKNOWN Condition: Surgical Menopause
NCTID: NCT01846416
Title: A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR] Study Summary: This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression. Eligible participants will be categorized in to three groups as follows: # Participants with no prior chemotherapy for advanced disease; # Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants); # Participants who are 2L+ and previously treated for brain metastases. Sponsor: Genentech, Inc. Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody Start Date: 2013-05-30 Last Updated: 2019-01-08 Number of Patients: 138 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT04737382
Title: Osimertinib Resistance in Patients With Non-small-cell Lung Carcinoma That Have Progressed. Study Summary: Initially, patients with EGFR mutation positive NSCLC respond well to osimertinib, a third generation EGFR tyrosine kinase inhibitor (TKI), but eventually progress. Upon progression multiple resistance mechanisms have been described and new therapeutic strategies are being developed to target these resistance mechanisms. Thorough and complete osimertinib resistance analysis enables optimal treatment decision making and might identify new targets for molecular treatment, thereby potentially improving patient outcome. Sponsor: The Netherlands Cancer Institute Intervention: biopsy Start Date: 2019-08-22 Last Updated: 2023-10-10 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Non-small-cell Lung Carcinoma
NCTID: NCT04189445
Title: Futibatinib in Patients With Specific FGFR Aberrations Study Summary: The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma <math display="block">iCCA</math>); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements. Sponsor: Taiho Oncology, Inc. Intervention: Futibatinib Start Date: 2020-08-24 Last Updated: 2023-06-06 Number of Patients: 115 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced or Metastatic Solid Tumor
NCTID: NCT01024582
Title: Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see how well it works in treating patients with early-stage breast cancer. Sponsor: The Netherlands Cancer Institute Intervention: biopsy Start Date: 2009-10 Last Updated: 2017-09-27 Number of Patients: 139 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02112682
Title: Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy Study Summary: STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate. HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates. Sponsor: Maastricht University Medical Center Intervention: Completion axillary treatment Start Date: 2014-06 Last Updated: 2018-05-09 Number of Patients: 52 Recruitment Status: TERMINATED Condition: Breast Neoplasms
NCTID: NCT03540420
Title: Atezolizumab After Concurrent Chemo-radiotherapy Versus Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer Study Summary: Some patients with limited disease small-cell lung cancer (LD SCLC) are cured after chemo-radiotherapy, but the majority relapse and die from their cancer. Better therapy is needed. Immunotherapy represents the largest advance in cancer therapy in recent years and has demonstrated promising activity in SCLC. In this study we will investigate whether atezolizumab prolongs survival in LD SCLC patients who have undergone chemo-radiotherapy. Sponsor: Norwegian University of Science and Technology Intervention: Atezolizumab Start Date: 2018-07-31 Last Updated: 2023-05-06 Number of Patients: 212 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small-cell Lung Cancer
NCTID: NCT02566993
Title: Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer Study Summary: Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line. Sponsor: PharmaMar Intervention: Lurbinectedin (PM01183) Start Date: 2016-08-30 Last Updated: 2021-10-28 Number of Patients: 613 Recruitment Status: COMPLETED Condition: Small-cell Lung Cancer
NCTID: NCT03150368
Title: Extended Use of ModraDoc006/r Study Summary: This is a study for extended use of ModraDoc006/r in patients with advanced solid tumours, available after completed treatment in one of the phase I trials with ModraDoc006/r. The primary goal is to explore the safety of extended use. Sponsor: Modra Pharmaceuticals Intervention: ModraDoc006/r Start Date: 2017-05-10 Last Updated: 2021-10-19 Number of Patients: 17 Recruitment Status: COMPLETED Condition: Advanced Solid Tumours
NCTID: NCT00070005
Title: J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma Study Summary: RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum. PURPOSE: This randomized phase III trial is studying how well J-pouch coloanal anastomosis works compared to side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum. Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Intervention: conventional surgery Start Date: 2002-06 Last Updated: 2013-08-07 Number of Patients: 100 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT02324452
Title: Safety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines Study Summary: In this study it will be determined whether the rate of severe toxicity associated with fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished by individualized dosing of fluoropyrimidines based on upfront genotypic assessment of dihydropyrimidine dehydrogenase (DPD) deficiency. In addition to the genotyping, the DPD phenotype of all patients will be determined by measuring the baseline dihydrouracil/uracil (DHU/U) ratio, in order to investigate whether phenotype-guided treatment can further improve patient safety. In a subgroup of patients, other phenotyping methods will be tested: measuring the plasma levels of uracil after a uracil test dose and a uracil breath test after a dose of <math display="block">2-13C</math> -labeled uracil. To validate these tests, these phenotyping results will be compared with the results of a DPD activity assay (which measures DPD enzyme activity in peripheral blood mononuclear cells), which is considered the gold standard in measuring DPD phenotype. Sponsor: The Netherlands Cancer Institute Intervention: Fluoropyrimidine (capecitabine or 5-fluorouracil) Start Date: 2015-03 Last Updated: 2018-05-11 Number of Patients: 1103 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT00043004
Title: Chemotherapy and Bevacizumab With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread by blocking blood flow. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases. PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab, and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bevacizumab Start Date: 2002-05 Last Updated: 2012-09-24 Number of Patients: 119 Recruitment Status: TERMINATED Condition: Colorectal Cancer
NCTID: NCT05242926
Title: Absorption and Excretion of Oral Docetaxel Study Summary: This is an open-label, phase I study to investigate the influence of the bi-daily weekly dosing of ModraDoc006/ritonavir on the absorption and excretion of docetaxel in patients with advanced solid tumours. The pharmacokinetics, absorption and excretion of docetaxel will be investigated during the study. Patients will receive 30 mg in the morning / 20 mg in the afternoon ModraDoc006 with BID 100 mg ritonavir in a fasted condition (i.e. at least 1 hour before or 2 hours after any food assumption), followed by collection of plasma, faeces and urine samples. Sponsor: Modra Pharmaceuticals Intervention: ModraDoc006/r Start Date: 2017-10 Last Updated: 2022-02-16 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Solid Tumor, Adult
NCTID: NCT00066391
Title: Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer Study Summary: RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2003-06 Last Updated: 2012-09-24 Number of Patients: NA Recruitment Status: COMPLETED Condition: Penile Cancer
NCTID: NCT04625205
Title: NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma Study Summary: Study to investigate the safety and activity of NEO-PTC-01 in patients with unresectable or metastatic melanoma. NEO-PTC-01 is an autologous personalized T cell (PTC) product for adoptive cell therapy that is manufactured ex vivo and targets neoantigens displayed on the patient’s tumor and the tumor microenvironment. The study will be conducted in two parts, Part 1 (Dose Finding) and Part 2 (Dose Expansion). The dose-finding part of the study will test two doses of NEO-PTC-01 and will be structured according to a 3+3 dose escalation design. After the highest tolerated NEO-PTC-01 dose is identified, 2 additional evaluations in Part 1 are planned, a cohort to investigate NEO-PTC-01 in combination with interleukin (IL)-2 and another cohort introducing α programmed cell death protein 1 (αPD-1) therapy. The dose expansion part of the study will test the dose deemed to be safe in the dose-finding part of the study in an expanded cohort of patients to further define the safety of NEO-PTC-01. Sponsor: BioNTech US Inc. Intervention: NEO-PTC-01 Start Date: 2020-12-01 Last Updated: 2023-10-27 Number of Patients: 72 Recruitment Status: RECRUITING Condition: Unresectable Melanoma
NCTID: NCT02988817
Title: Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors Study Summary: The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors Sponsor: Genmab Intervention: Enapotamab vedotin (HuMax-AXL-ADC) Start Date: 2016-11-23 Last Updated: 2023-08-01 Number of Patients: 306 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT04075305
Title: The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study Study Summary: The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients’ survival, local, and regional tumor control and quality of life. Sponsor: UMC Utrecht Intervention: Radiation therapy Start Date: 2019-02-01 Last Updated: 2023-09-28 Number of Patients: 8000 Recruitment Status: RECRUITING Condition: Oncology
NCTID: NCT00028717
Title: Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. It is not yet known if combination chemotherapy plus filgrastim is more effective with or without rituximab in treating non-Hodgkin’s lymphoma. PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy plus filgrastim with or without rituximab in treating older patients who have non-Hodgkin’s lymphoma. Sponsor: Commissie Voor Klinisch Toegepast Onderzoek Intervention: filgrastim Start Date: 2001-02 Last Updated: 2013-09-17 Number of Patients: 400 Recruitment Status: UNKNOWN Condition: Lymphoma
NCTID: NCT05267106
Title: Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations Study Summary: This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal. Sponsor: Incyte Corporation Intervention: Pemigatinib Start Date: 2022-05-20 Last Updated: 2023-11-15 Number of Patients: 164 Recruitment Status: RECRUITING Condition: Glioblastoma
NCTID: NCT03631706
Title: M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC) Study Summary: The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: M7824 Start Date: 2018-10-01 Last Updated: 2023-10-27 Number of Patients: 304 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT02684006
Title: A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) Study Summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma Sponsor: Pfizer Intervention: Avelumab (MSB0010718C) Start Date: 2016-03-23 Last Updated: 2023-11-09 Number of Patients: 888 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Cancer
NCTID: NCT01870609
Title: Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma Study Summary: This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the study, each subject must have tumor Merlin status(high or low) established by immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1 ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be stratified by tumor Merlin status (high versus low). Progression will be assessed both locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression or other discontinuation criteria are met. Following documentation of nonfatal disease progression, all subjects will be followed for overall survival by telephone contact every 2 months until end of life or the close of the study. Sponsor: Verastem, Inc. Intervention: defactinib (VS-6063) Start Date: 2013-09 Last Updated: 2017-01-30 Number of Patients: 344 Recruitment Status: TERMINATED Condition: Malignant Pleural Mesothelioma
NCTID: NCT03834506
Title: Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-02 Last Updated: 2023-08-25 Number of Patients: 1030 Recruitment Status: COMPLETED Condition: Prostatic Neoplasms
NCTID: NCT04839991
Title: Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours. Study Summary: FIH, Phase 1, open-label, multi centre study of CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours to assess safety and tolerability to determine MTD and preliminary RP2D.In addition this study will assess the safety and efficacy of CB307 when given in combination with pembrolizumab (KEYTRUDA®) in patients with metastatic PSMA+ castration-resistant cancer Sponsor: Crescendo Biologics Ltd. Intervention: CB307 Start Date: 2021-06-08 Last Updated: 2023-11-18 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Advanced and/or Metastatic Solid Tumours
NCTID: NCT00022191
Title: Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2001-05 Last Updated: 2013-06-12 Number of Patients: 608 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT04489771
Title: A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013) Study Summary: This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective response rate (ORR). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2020-09-13 Last Updated: 2023-10-19 Number of Patients: 154 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT01702571
Title: A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment Study Summary: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2012-11-27 Last Updated: 2022-04-04 Number of Patients: 2185 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT05078671
Title: Pharmacokinetic Boosting of Olaparib to Improve Exposure, Tolerance and Cost-effectiveness Study Summary: Olaparib is a poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, originally used for the maintenance treatment of women with platinum-sensitive relapsed breast cancer gene (BRCA)-mutated high grade serious epithelial ovarian, fallopian tube, or peritoneal cancer, who are in response to platinum-based chemotherapy. Over the last two years, several therapeutic indications have been added to the drug label, such as first-line platinum-sensitive BRCA-mutated high grade serious epithelial ovarian, fallopian tube, or peritoneal cancer, germline BRCA1/2-mutated, human epidermal growth factor 2 (HER2-)negative, locally advanced or metastatic breast cancer and BRCA1/2-mutated metastatic castration-resistant prostate cancer, who have progressed following prior therapy. Since olaparib is very expensive, this increase of treatment population will have a significant impact on health care expenditures. To keep healthcare affordable and accessible for all patients, innovative strategies are warranted to reduce the dose of expensive drugs, without reduction of efficacy. For olaparib, pharmacokinetic (PK) boosting can be applied. PK boosting is the lay term for administering a non-therapeutic active strong inhibitor of a metabolic enzyme, for example the cytochrome p450 enzyme 3A (CYP3A), together with a therapeutic drug that is metabolized by the same enzyme. Boosting thus increases the concentration of the therapeutic drug and allows lower doses to be administered to patients. Hence, coadministration of a reduced dose of olaparib with cobicistat, a non-therapeutic, strong inhibitor of the CYP3A can lead to equivalent exposure to olaparib. Furthermore, inhibition of CYP3A could lead to less PK variability since metabolic capacity is a prominent cause for (intra- and inter-individual) variability in systemic exposure. Predictable olaparib exposure will reduce the number of patients who are unintentionally under- or overtreated. Lastly, tumor tissue itself may express CYP3A as a detoxification or resistance mechanism. Theoretically, PK boosting may also overcome CYP3A-mediated drug resistance. The purpose of this study is to establish the efficacy, safety and feasibility of co-administering olaparib with the PK booster cobicistat with the aim to implement boosting approach for olaparib in routine practice. The study is subdivided in two parts. In part A of the study the equivalent exposure of boosted low dose olaparib is determined compared to the normal dose. In part B of the study, non-inferiority of the boosted olaparib regimen will be confirmed. Sponsor: Radboud University Medical Center Intervention: Olaparib Start Date: 2021-12-15 Last Updated: 2022-10-24 Number of Patients: 160 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT00085475
Title: Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma Study Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: imatinib mesylate Start Date: 2004-04 Last Updated: 2012-09-24 Number of Patients: 17 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT03477175
Title: Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials Study Summary: This study will be conducted to assess the long-term safety of study drug(s) in participants who are enrolled in Eisai-sponsored lenvatinib studies. Sponsor: Eisai Inc. Intervention: E7080 Start Date: 2018-08-16 Last Updated: 2023-10-06 Number of Patients: 50 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors
NCTID: NCT05007106
Title: MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Study Summary: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2021-09-16 Last Updated: 2023-11-24 Number of Patients: 610 Recruitment Status: RECRUITING Condition: Uterine Cervical Neoplasms
NCTID: NCT00041249
Title: Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: brostallicin Start Date: 2002-05 Last Updated: 2012-07-18 Number of Patients: 64 Recruitment Status: COMPLETED Condition: Gastrointestinal Stromal Tumor
NCTID: NCT02488850
Title: Determination of Peripheral Immune Cell Activity During Treatment With Either Surgery or Radiotherapy in Patients With Early Stage NSCLC Study Summary: Rationale: An anatomical surgical resection is considered to be the standard of care in fit patients who present with early stage non-small cell lung cancer (NSCLC). However, surgery is less frequently performed in both elderly patients (aged ≥75 years), who represent the fastest-growing group of patients with stage I/II NSCLC, and in patients who have significant co-morbidity. Following the introduction of stereotactic ablative radiotherapy (SABR), an outpatient treatment that is typically delivered in between 3-8 fractions, the median survival of all elderly patients undergoing radiotherapy in The Netherlands increased by 9.3 months. Randomized trials comparing SABR and surgery have yet to be completed and results of the ongoing ACOSOG Z4032 studies will not be available in the within 5 years. A recent data retrospective study comparing both modalities has raised interesting questions about the impact of local therapy on recurrence patterns. It was found that a better loco-regional disease control rate was achieved with SABR. Objective: To study the effect of surgery and SABR on both immunostimulatory (with primary endpoint CD8 positive cells) and immunosuppressive cells in peripheral blood in patients with early stage non-small cell lung cancer who are treated with either modality. Study population: 40 patients with cT1-2aN0M0 either cytologically or histologically proven NSCLC. Main study parameters/endpoints: To determine whether an increase in CD8 activity can be established after SABR in patients with early stage lung cancer and to compare this increase with that in patients undergoing a surgical intervention. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Only risks in participation are the risks with drawing blood. Subjects will not have any benefits. This pilot study will be used to generate information concerning both treatments useful for the decision to plan a future study in a larger series of patients. Sponsor: Erasmus Medical Center Intervention: Surgery Start Date: 2012-12 Last Updated: 2023-02-15 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT02292407
Title: Prospective Pilot Study ANDPrecise Study Summary: This study aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited. Sponsor: The Netherlands Cancer Institute Intervention: LigaSure Precise instrument Start Date: 2012-06 Last Updated: 2014-11-17 Number of Patients: 20 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT01307397
Title: A Study of Vemurafenib in Participants With Metastatic Melanoma Study Summary: This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer <math display="block">AJCC</math>) metastatic melanoma. Sponsor: Hoffmann-La Roche Intervention: Vemurafenib Start Date: 2011-03-01 Last Updated: 2017-12-18 Number of Patients: 3219 Recruitment Status: COMPLETED Condition: Malignant Melanoma
NCTID: NCT00049595
Title: Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin’s lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 2002-08 Last Updated: 2023-11-09 Number of Patients: 552 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT00103051
Title: Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and cisplatin together with gefitinib before surgery may shrink the tumor so it can be removed. PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with gefitinib works in treating patients who are undergoing surgery for stage III non-small cell lung cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2004-12 Last Updated: 2012-07-16 Number of Patients: NA Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT02826512
Title: A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients Study Summary: Patients with locally recurrent BRCA1-like, HER2-negative breast cancer that cannot be treated with curative intent by local treatment (surgery, radiotherapy +/- hyperthermia) or patients with metastatic BRCA1-like, HER2-negative breast cancer that have received a maximum of one prior line of treatment for incurable disease will be treated with Niraparib until disease progression Sponsor: The Netherlands Cancer Institute Intervention: Niraparib Start Date: 2018-05-15 Last Updated: 2022-07-18 Number of Patients: 9 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT00012051
Title: Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by the chemotherapy. Monoclonal antibodies, such as rituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known if giving more than one drug (combination chemotherapy) plus peripheral stem cell transplant is more effective with or without monoclonal antibody therapy in treating non-Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is studying how well chemotherapy plus peripheral stem cell transplant with or without monoclonal antibody therapy works in treating patients with relapsed non-Hodgkin’s lymphoma. Sponsor: Commissie Voor Klinisch Toegepast Onderzoek Intervention: filgrastim Start Date: 2000-09 Last Updated: 2013-08-12 Number of Patients: 340 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT00547651
Title: AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy Study Summary: This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer. Sponsor: Celgene Intervention: Amrubicin Start Date: 2007-09-01 Last Updated: 2019-11-06 Number of Patients: 637 Recruitment Status: COMPLETED Condition: Small Cell Lung Cancer
NCTID: NCT03915951
Title: An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer Study Summary: This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mutant metastatic non-small cell lung cancer (NSCLC). Patients who are either treatment-naïve, OR who have received 1) first-line treatment with standard platinum-based chemotherapy, OR 2) first-line treatment with an anti-programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) inhibitor given alone or in combination with platinum-based chemotherapy will be enrolled. Sponsor: Pfizer Intervention: encorafenib Start Date: 2019-06-04 Last Updated: 2023-10-30 Number of Patients: 98 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT00121719
Title: An Open Label Dose Escalation Study Of E7080 Study Summary: The purpose of this study is to determine the maximum tolerated dose (MTD) of lenvatinib in patients with solid tumors or lymphomas. Sponsor: Eisai Inc. Intervention: Lenvatinib Start Date: 2005-07-01 Last Updated: 2023-06-22 Number of Patients: 82 Recruitment Status: COMPLETED Condition: Solid Tumor or Lymphoma
NCTID: NCT01844986
Title: Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. Study Summary: Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy. Sponsor: AstraZeneca Intervention: Olaparib 300mg tablets Start Date: 2013-08-26 Last Updated: 2023-11-28 Number of Patients: 450 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Newly Diagnosed
NCTID: NCT02836548
Title: HDAC Inhibitor Vorinostat in Resistant BRAF V600 Mutated Advanced Melanoma Study Summary: This is a mono-center open-label proof-of-concept pharmacologic study to explore the efficacy and safety of vorinostat in advanced BRAF mutated melanoma, which became resistant for BRAF-inhibitors or the combination of BRAF- and MEK-inhibitors. Sponsor: The Netherlands Cancer Institute Intervention: Vorinostat Start Date: 2016-06 Last Updated: 2018-10-17 Number of Patients: 22 Recruitment Status: UNKNOWN Condition: Melanoma
NCTID: NCT04148066
Title: ctDNA Guided Treatment of Early Resistance to Targeted Treatment Study Summary: The current strategy is to test for treatment resistance at the time of radiological progression and design subsequent treatment based on the mechanism of resistance. However, upon disease progression patients tend to deteriorate quickly and 30% - 40% of patients will not be in the clinical condition to receive next line treatment. Therefore, there is a potential for early resistance identification and directing treatment against it in order to improve patient outcome. Sponsor: The Netherlands Cancer Institute Intervention: ctDNA blood sample Start Date: 2019-07-17 Last Updated: 2023-10-10 Number of Patients: 104 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03864042
Title: Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors Study Summary: This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide/breast cancer resistance protein (OATP/BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase. Sponsor: Pfizer Intervention: losartan Start Date: 2018-01-02 Last Updated: 2023-06-08 Number of Patients: 56 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT03448042
Title: A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers Study Summary: This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers. Sponsor: Genentech, Inc. Intervention: Runimotamab Start Date: 2018-06-06 Last Updated: 2023-11-02 Number of Patients: 537 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT04607421
Title: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer Study Summary: The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. The study team will monitor how each participant responds to the study treatment for up to about 3 years. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2020-12-21 Last Updated: 2023-09-11 Number of Patients: 815 Recruitment Status: RECRUITING Condition: Neoplasms
NCTID: NCT02428842
Title: Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4) Study Summary: Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points. Sponsor: Institut Curie Intervention: Tumor biopsies Start Date: 2013-10-24 Last Updated: 2023-01-20 Number of Patients: 419 Recruitment Status: COMPLETED Condition: Cervical Cancer
NCTID: NCT01097265
Title: Study of Micrometastases in Patients With Stage I or Stage II Localized Colon Cancer That Can Be Removed by Surgery Study Summary: RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may help doctors find patients who are at risk of developing micrometastases and plan better treatment. PURPOSE: This randomized phase II/III trial is studying micrometastases in patients with stage I or stage II localized colon cancer that can be removed by surgery. Sponsor: Jeroen Bosch Ziekenhuis Intervention: capecitabine Start Date: 2010-07 Last Updated: 2013-08-12 Number of Patients: 1500 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT04586231
Title: A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) Study Summary: This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival. Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2021-02-25 Last Updated: 2023-08-14 Number of Patients: 708 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT01320085
Title: A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma Study Summary: The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations. Sponsor: Pfizer Intervention: MEK162 Start Date: 2011-03-24 Last Updated: 2023-08-03 Number of Patients: 183 Recruitment Status: COMPLETED Condition: BRAF or NRAS Mutant Metastatic Melanoma
NCTID: NCT02315066
Title: Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566 Study Summary: To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose. Sponsor: Pfizer Intervention: PF-04518600 Start Date: 2015-04-23 Last Updated: 2022-04-21 Number of Patients: 174 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT01874353
Title: Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy Study Summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy. Sponsor: AstraZeneca Intervention: Olaparib 300mg tablets Start Date: 2013-09-03 Last Updated: 2023-10-23 Number of Patients: 327 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Platinum Sensitive
NCTID: NCT02994953
Title: A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12) Study Summary: The study consists of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase will evaluate the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase will assess the safety and clinical activity of the combination regimen in selected tumor types. In Expansion phase subjects who have completed the combination treatment of avelumab at a given dose level of M9241, a safety review will be performed by the Safety monitoring committee in order to make a decision on the next dose level. Successive cohorts of 3 to 6 subjects will be treated with escalating doses of M9241 with avelumab intravenous (IV). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2017-01-31 Last Updated: 2020-12-17 Number of Patients: 52 Recruitment Status: TERMINATED Condition: Advanced Solid Tumors
NCTID: NCT02196961
Title: Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies vs Observation Study Summary: Primary objective: To estimate the efficacy of adjuvant nivolumab monotherapy in completely resected MCC patients Primary endpoint: Disease-free survival (DFS) rate evaluated at 12, 24 and 48 months after date of randomization Secondary Objectives: To describe the safety profile and additional efficacy parameters of the nivolumab treatment in MCC Secondary endpoints: * Adverse events according to CTCAE, Version 4.0 criteria, that are related to the administration of nivolumab * Disease-free survival (DFS) * Overall survival (OS) and OS rates at 12, 24 and 48 months after randomization Explorative Endpoints: * Distant-metastases-free survival (DMFS) and DMFS rate at 12, 24 and 48 months after randomization * Identification and validation of prognostic/predictive biomarkers * Quality of life (EORTC QLQ-C30) until 24 months after randomization Sponsor: Prof. Dr. med. Dirk Schadendorf Intervention: Nivolumab Start Date: 2014-06 Last Updated: 2023-11-28 Number of Patients: 180 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Merkel Cell Carcinoma
NCTID: NCT03273153
Title: A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma Study Summary: This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma. Sponsor: Hoffmann-La Roche Intervention: Cobimetinib Start Date: 2017-12-11 Last Updated: 2022-09-21 Number of Patients: 446 Recruitment Status: TERMINATED Condition: Advanced BRAFV600 Wild-type Melanoma
NCTID: NCT00407264
Title: Randomized Trial of Fluticasone in Bronchial Premalignancy Study Summary: The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers Sponsor: Amsterdam UMC, location VUmc Intervention: Fluticasone propionate Start Date: 2002-02 Last Updated: 2006-12-04 Number of Patients: 90 Recruitment Status: COMPLETED Condition: Bronchogenic Carcinoma
NCTID: NCT02811861
Title: Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma Study Summary: The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review <math display="block">IIR</math> using Response Evaluation Criteria in Solid Tumors <math display="block">RECIST 1.1</math>) as first-line treatment in participants with advanced renal cell carcinoma (RCC). Sponsor: Eisai Inc. Intervention: Lenvatinib Start Date: 2016-10-13 Last Updated: 2023-07-10 Number of Patients: 1069 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT00094653
Title: MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma Study Summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response <math display="block">PR/CR</math>); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379. Sponsor: Bristol-Myers Squibb Intervention: MDX-010 (anti-CTLA4) monoclonal antibody Start Date: 2004-09 Last Updated: 2011-07-11 Number of Patients: 1783 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT04289077
Title: Quality of Life of Patients With Desmoid-type Fibromatosis Study Summary: Rationale: Desmoid-type fibromatosis (DTF) is a rare, histologically benign, soft tissue tumour. Although incapable of metastasizing, the clinical course is unpredictable and can be aggressive because of local invasive growth. Various treatments are available including; surgical resection, radiotherapy, hormonal therapy and chemotherapy. Nowadays there is a trend towards a more conservative strategy with a wait and see policy because of high recurrence rates after surgical resection. Health-related quality of life (HRQL) is a corner stone in treatment choice and can be used during the disease for monitoring the impact of the disease on physical, psychological and social level. Additionally, HRQL can be in important endpoint for future clinical trials. Today, no HRQL-tools are available which capture the needs of DTF patients. The hypothesis is that patients with DTF have issues on several HRQL domains including physical, social and emotional well-being. For this reason we developed a list of items based on previous research. This study aims to evaluate HRQL issues experienced by DTF patients. Purpose: Multi-centre, cross-sectional, observational study to measure HRQL of DTF patients and to evaluate the prevalence of the experienced problems. Sponsor: Erasmus Medical Center Intervention: Questionnaires Start Date: 2020-08-06 Last Updated: 2023-09-07 Number of Patients: 156 Recruitment Status: COMPLETED Condition: Desmoid Tumor
NCTID: NCT00513877
Title: Bortezomib in Treating Patients With Malignant Pleural Mesothelioma Study Summary: RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma. Sponsor: Cancer Trials Ireland Intervention: bortezomib Start Date: 2006-05 Last Updated: 2014-12-31 Number of Patients: 33 Recruitment Status: COMPLETED Condition: Malignant Mesothelioma
NCTID: NCT03486873
Title: Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) Study Summary: The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-08-21 Last Updated: 2023-11-27 Number of Patients: 2300 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT01855061
Title: Biomarker Development for Response Prediction by DNA Mutational Analysis Study Summary: The purpose of this study is to determine whether it is possible to predict response to chemotherapy in patients with metastatic cancer who are treated with irinotecan by determining the mutational profile of the tumor. Sponsor: P.O. Witteveen Intervention: Biopsy Start Date: 2011-05 Last Updated: 2018-03-09 Number of Patients: 79 Recruitment Status: TERMINATED Condition: Neoplasm Metastasis
NCTID: NCT01265810
Title: Caphosol in Oral Mucositis Due to Targeted Therapy Study Summary: Targeted therapies such as multi-targeted tyrosine kinase inhibitors (TKI) and mammalian target of rapamycin inhibitors (mTORI) in renal cell carcinoma (RCC), demonstrate a high level of efficacy with acceptable tolerability. Currently, there are five approved targeted therapies available for RCC: sunitinib (Sutent®), sorafenib (Nexavar®), pazopanib (Votrient®), temsirolimus (Torisel®), and everolimus (Afinitor®). Hepatocellular carcinoma treated with sorafenib and gastro intestinal stromal tumors patients treated with sunitinib will be included, too. Since this agents have dermatological adverse events in common, with oral mucositis (OM), hand-foot skin reaction (HFSR) and papulopustular eruption (PPE) as an disabling side effect, we require evidence based management options to prevent and treat these adverse events. The incidence of OM of any grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%, temsirolimus 41%, and everolimus 44%. Recent data suggest that TKI and mTORI associated OM is distinct from conventional mucositis and more closely resembles aphthous OM. Recently, supersaturated calcium-phosphate rinse (Caphosol®), a Ca2+/PO43- mouth rinse, became available to prevent or treat OM. The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes which include oral intake, swallowing function and pain associated with incidence of grade ≥ 1 oral side effects and the anticancer therapy cessation in patients treated with selected targeted anticancer therapy. Patients with OM > grade 0 on targeted therapy will be randomly allocated to receive either Caphosol® or NaCl 0.9% rinse for two weeks. After the first rinse period all patients will switch to the opposite treatment arm (NaCl 0.9% or Caphosol®) for another two weeks. Duration of oral side effects, severity, pain, dose of analgesics and tolerability will be assessed weekly with the Modified-VHNSS-version-2.0 oral-specific questionnaire. Patients will be stratified by targeted anticancer agent and per tumor type (pre-defined cohorts). Objective severity of oral side effects will be assessed using the NCI-CTCAE v4.0. Correlation of subjective Modified-VHNSS-version-2.0 scores with the objective NCI-CTCAE grade, sex, age, targeted therapy type, and cancer type will be conducted. Sponsor: Impaqtt Foundation Intervention: supersaturated calcium-phosphate Start Date: 2011-11 Last Updated: 2017-11-13 Number of Patients: 64 Recruitment Status: COMPLETED Condition: Oral Complaints
NCTID: NCT03024996
Title: A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy Study Summary: This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-01-03 Last Updated: 2023-08-03 Number of Patients: 778 Recruitment Status: TERMINATED Condition: Renal Cell Carcinoma
NCTID: NCT03374488
Title: Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma Study Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease. Sponsor: Incyte Corporation Intervention: Pembrolizumab Start Date: 2017-12-22 Last Updated: 2021-11-30 Number of Patients: 84 Recruitment Status: COMPLETED Condition: UC (Urothelial Cancer)
NCTID: NCT05779631
Title: Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm Study Summary: A two-arm multicenter randomised controlled trial, comparing progression free survival, time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with suspicion of muscle-invasive bladder cancer. Sponsor: Radboud University Medical Center Intervention: mpMRI plus a same-day cystoscopic bladder biopsy Start Date: 2023-07 Last Updated: 2023-04-07 Number of Patients: 360 Recruitment Status: NOT_YET_RECRUITING Condition: Bladder Cancer
NCTID: NCT02367794
Title: A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131] Study Summary: This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody Start Date: 2015-06-11 Last Updated: 2022-03-21 Number of Patients: 1021 Recruitment Status: COMPLETED Condition: Squamous Non-Small Cell Lung Cancer
NCTID: NCT03147378
Title: Food Effect Study of ModraDoc006 in Combination With Ritonavir Study Summary: This study aims to evaluate the effect of food on the pharmacokinetics of ModraDoc006 in combination with ritonavir, in an open-label, cross-over design. Patients will be randomized into two treatment groups receiving ModraDoc006/r week 1 under fasting and week 2 under fed condition, or vice versa. Sponsor: Modra Pharmaceuticals Intervention: ModraDoc006/r Start Date: 2017-05-10 Last Updated: 2021-10-19 Number of Patients: 18 Recruitment Status: COMPLETED Condition: Solid Tumor, Adult
NCTID: NCT01286896
Title: Use of Individual Pharmacokinetically (PK)-Guided Sunitinib Dosing: A Feasibility Study in Patients With Advanced Solid Tumors Study Summary: The purpose of this prospective study is to determine the safety and feasibility of pharmacokinetically (PK) guided dosing of sunitinib in 30 patients. At day 15 ± 1day, day 29 ± 1day and after 8 weeks ± 1day of sunitinib treatment sunitinib and SU12662 trough levels will be measured. Depending on the sunitinib and SU12662 trough levels (and toxicity) dose adjustments will be made. Sponsor: The Netherlands Cancer Institute Intervention: Sunitinib Start Date: 2011-03 Last Updated: 2011-10-10 Number of Patients: 30 Recruitment Status: UNKNOWN Condition: Malignant Solid Tumour
NCTID: NCT00706095
Title: Study Of Eribulin (E7389) In Patients With Advanced Solid Tumors And Normal Or Reduced Hepatic Function As Per Child-Pugh System Study Summary: This is an open-label, three-parallel group pharmacokinetic study. Patients with advanced solid tumors will be assigned to one of three groups to receive I.V. doses of eribulin (E7389). The three groups are: normal hepatic function, mild hepatic impairment (Child-Pugh A) and moderate hepatic impairment (Child-Pugh B) according to the Child-Pugh System for classifying hepatic impairment. Sponsor: Eisai Inc. Intervention: E7389 Start Date: 2008-02 Last Updated: 2012-03-27 Number of Patients: 18 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT04287894
Title: Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment Study Summary: A Phase Ib, Open-label, Single-center study to assess the safety of cancer-immunotherapy induction with Tremelimumab and Durvalumab prior to Chemoradiotherapy in the treatment of locally advanced NSCLC. Sponsor: The Netherlands Cancer Institute Intervention: Durvalumab Start Date: 2018-12-28 Last Updated: 2020-02-27 Number of Patients: 34 Recruitment Status: UNKNOWN Condition: Stage III NSCLC
NCTID: NCT05352672
Title: Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma Study Summary: The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS) The secondary objectives of the study are: * To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) * To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab * To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component * To assess immunogenicity of fianlimab and cemiplimab * To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults * To characterize safety and tolerability of treatment in patients 12 to <18 years of age * To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age * To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab * To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years Sponsor: Regeneron Pharmaceuticals Intervention: Fianlimab Start Date: 2022-07-14 Last Updated: 2023-11-24 Number of Patients: 1590 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT03785925
Title: A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer Study Summary: The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients. Sponsor: Nektar Therapeutics Intervention: Bempegaldesleukin Start Date: 2019-04-29 Last Updated: 2023-03-28 Number of Patients: 192 Recruitment Status: COMPLETED Condition: Urinary Bladder Neoplasm
NCTID: NCT02864992
Title: Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION) Study Summary: This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Tepotinib Start Date: 2016-09-13 Last Updated: 2023-06-09 Number of Patients: 337 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification
NCTID: NCT00014612
Title: Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: axillary lymph node dissection Start Date: 2001-02 Last Updated: 2013-10-29 Number of Patients: 4813 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02729558
Title: Local Radiotherapy Following Complete Resection of a Brain Metastasis Study Summary: Objective: To improve local control following complete resection of a single brain metastasis using fractionated local stereotactic radiotherapy, whilst maintaining neurological functioning, neurocognition and quality of life. Study design: Multicenter randomized phase III, with at least three high-volume Dutch centers participating in the trial. Stratification on primary tumor type and age. Study population: Patients undergoing complete resection of a single brain metastasis, confirmed by an early (i.e. within 72 hours) postoperative contrast-enhanced MR scan. Study intervention: Patients will be randomized between observation alone (standard arm) and local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity (study arm). Main study parameters: Primary objective: local control rate at 6 months. Secondary objectives: local control rate at 12 months, neurological functioning, freedom from clinical neurological progression, performance status, quality of life, toxicity, steroid use, neurocognition and overall survival. Sponsor: Amsterdam UMC, location VUmc Intervention: local SRT Start Date: 2015-05 Last Updated: 2019-05-20 Number of Patients: 70 Recruitment Status: TERMINATED Condition: Brain Neoplasms
NCTID: NCT04895358
Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) Study Summary: The safety and efficacy of pembrolizumab plus the investigator’s choice of chemotherapy will be assessed compared to placebo plus the investigator’s choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10. Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2021-06-18 Last Updated: 2023-11-27 Number of Patients: 800 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT03539536
Title: Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer Study Summary: This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3). Sponsor: AbbVie Intervention: Telisotuzumab vedotin Start Date: 2018-10-10 Last Updated: 2023-07-14 Number of Patients: 270 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT04862780
Title: (SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC Study Summary: This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-945, a selective EGFR inhibitor, as monotherapy or in combination with osimertinib. Sponsor: Blueprint Medicines Corporation Intervention: BLU-945 Start Date: 2021-06-29 Last Updated: 2023-09-06 Number of Patients: 190 Recruitment Status: RECRUITING Condition: Lung Neoplasms
NCTID: NCT01719380
Title: Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer Study Summary: This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer Sponsor: Pfizer Intervention: LGX818 Start Date: 2012-11-23 Last Updated: 2021-06-23 Number of Patients: 156 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT04191096
Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) Study Summary: This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-02-12 Last Updated: 2023-11-18 Number of Patients: 1251 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Hormone-Sensitive Prostate Cancer
NCTID: NCT04916236
Title: Combination Therapy of RMC-4630 and LY3214996 in Metastatic KRAS Mutant Cancers Study Summary: This is a Phase I/Ib study in which the safety of the combination therapy of RMC-4630 and LY3214996 in the treatment of KRAS mutant cancers will be studied. Sponsor: The Netherlands Cancer Institute Intervention: RMC-4630 Start Date: 2022-03-31 Last Updated: 2022-06-03 Number of Patients: 55 Recruitment Status: RECRUITING Condition: Pancreatic Cancer
NCTID: NCT02458638
Title: A Study of Atezolizumab in Advanced Solid Tumors Study Summary: The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody Start Date: 2015-07-16 Last Updated: 2021-06-04 Number of Patients: 474 Recruitment Status: COMPLETED Condition: Tumors
NCTID: NCT03289962
Title: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors Study Summary: This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 <math display="block">anti-PD-L1</math> antibody). Sponsor: Genentech, Inc. Intervention: Autogene cevumeran Start Date: 2017-12-21 Last Updated: 2023-11-03 Number of Patients: 272 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT05116202
Title: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma) Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population. Sponsor: Hoffmann-La Roche Intervention: Nivolumab Start Date: 2022-02-02 Last Updated: 2023-11-13 Number of Patients: 336 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT00066378
Title: Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by reducing the production of estrogen. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining anastrozole with gefitinib may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locally recurrent breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: anastrozole Start Date: 2003-05 Last Updated: 2013-10-24 Number of Patients: 71 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03669718
Title: A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC Study Summary: This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b. Sponsor: ISA Pharmaceuticals Intervention: ISA101b Start Date: 2018-11-30 Last Updated: 2023-04-12 Number of Patients: 194 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of the Oropharynx
NCTID: NCT03686332
Title: PEnile Cancer Radio- and Immunotherapy CLinical Exploration Study Study Summary: Patients with advanced penile cancer have a poor prognosis (21% 2-year overall survival from moment of diagnosis) and high morbidity due to progressive locoregional disease. Translational studies show high rates of infiltrating immune cells and PD-L1 positivity, suggesting that immunotherapy may be beneficial in this disease. Atezolizumab, targeting PD-L1, is active in several cancer types and is generally well-tolerated. This study will investigate whether atezolizumab can be combined with radiotherapy to control locoregional lymph node disease. Furthermore, the activity of atezolizumab in advanced penile cancer patients will be investigated. Sponsor: The Netherlands Cancer Institute Intervention: Arm A: Atezolizumab and Radiotherapy Start Date: 2018-09-25 Last Updated: 2023-09-21 Number of Patients: 32 Recruitment Status: COMPLETED Condition: Penile Cancer
NCTID: NCT04626518
Title: Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B) Study Summary: Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-12-17 Last Updated: 2023-11-02 Number of Patients: 370 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT04503278
Title: A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX Study Summary: This is a Phase I/IIa, FIH, open-label, multicenter, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T/CLDN6 CAR-T(A) with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors. The trial started with CLDN6 RNA-LPX, a liposomal formulation comprising an unmodified RNA. In order to optimize CAR-T cell persistence in patients, an alternative RNA-LPX, CLDN6 modRNA-LPX, will be tested once the RP2D dose for CLDN6 CAR-T(A) ± CLDN6 RNA-LPX is identified. Sponsor: BioNTech Cell & Gene Therapies GmbH Intervention: CLDN6 CAR-T/CLDN6 CAR-T(A) Start Date: 2020-09-16 Last Updated: 2023-11-27 Number of Patients: 114 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT02031458
Title: A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer Study Summary: This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2014-01-22 Last Updated: 2020-01-06 Number of Patients: 667 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT01763164
Title: Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma Study Summary: Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival Sponsor: Pfizer Intervention: MEK162 Start Date: 2013-07-12 Last Updated: 2021-03-22 Number of Patients: 402 Recruitment Status: COMPLETED Condition: Metastatic or Unresectable Cutaneous Melanoma
NCTID: NCT00005584
Title: Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin’s lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 1998-10 Last Updated: 2023-02-15 Number of Patients: 1649 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT02321228
Title: Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers Study Summary: The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers. Sponsor: University Medical Center Nijmegen Intervention: Salpingectomy with delayed oophorectomy Start Date: 2015-01 Last Updated: 2022-05-18 Number of Patients: 510 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: BRCA1 Gene Mutation
NCTID: NCT00061984
Title: Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma Study Summary: RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: pegfilgrastim Start Date: 2003-04 Last Updated: 2014-10-27 Number of Patients: 455 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT02271828
Title: Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy Study Summary: STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate. HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates. Sponsor: Maastricht University Medical Center Intervention: Sentinel lymph node procedure Start Date: 2015-04 Last Updated: 2018-05-04 Number of Patients: 1644 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT03673501
Title: A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib Study Summary: This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off). Sponsor: Deciphera Pharmaceuticals LLC Intervention: DCC-2618 Start Date: 2019-02-11 Last Updated: 2021-01-06 Number of Patients: 426 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastrointestinal Stromal Tumors
NCTID: NCT02683941
Title: Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours Study Summary: This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary NETs. This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Phase will consist of two periods: Treatment Period and Follow-Up Period. The primary objective will be to describe the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects randomized to LAN with unresectable and/or metastatic well differentiated, typical or atypical bronchopulmonary neuroendocrine tumours. Recent updates of National Cancer Institute Cancer Network (NCCN) & European Neuroendocrine Tumor Society (ENETS) guidelines recommend SSA in first line for the treatment of locoregional unresectable or metastatic bronchopulmonary NETs as an option beyond ‘observation’ leading to slow and difficult recruitment in SPINET study. Consequently, it was decided to prematurely stop the recruitment in the SPINET study and to transition all subjects still treated in the double-blind phase to the open label (OL) treatment and follow-up phases following respective country approvals of Amendment #5. The new aim of this Phase 3, multicenter, prospective, randomized placebo-controlled clinical study is to describe the antitumor efficacy and safety of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) in subjects with well-differentiated, metastatic and/or unresectable, typical or atypical, bronchopulmonary NETs. Sponsor: Ipsen Intervention: Lanreotide (Autogel formulation) Start Date: 2017-03-06 Last Updated: 2022-07-06 Number of Patients: 77 Recruitment Status: TERMINATED Condition: Neuroendocrine Tumors in Lung
NCTID: NCT03147040
Title: AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer Study Summary: This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC Sponsor: The Netherlands Cancer Institute Intervention: Carboplatin Start Date: 2017-11-02 Last Updated: 2022-07-19 Number of Patients: 23 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT00068757
Title: Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2
eu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
Study Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining lonafarnib and trastuzumab with paclitaxel may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when given together with trastuzumab and paclitaxel in treating patients with HER2
eu-overexpressing stage IIIB, stage IIIC, or stage IV breast cancer.
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: trastuzumab Start Date: 2003-08 Last Updated: 2012-09-12 Number of Patients: 23 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03136640
Title: ModraDoc006/r in Metastatic Castration-resistant Prostate Cancer Study Summary: This is a safety, feasibility and pharmacokinetic study to confirm that the recommended safe dose and schedule of ModraDoc006/r (oral docetaxel with ritonavir) as determined in a previous phase I study is also safe and feasible in the target population of patients with CRPC. Sponsor: Modra Pharmaceuticals Intervention: ModraDoc006/r Start Date: 2017-04-26 Last Updated: 2021-10-19 Number of Patients: 23 Recruitment Status: COMPLETED Condition: Castration-resistant Prostate Cancer
NCTID: NCT04518124
Title: Propranolol in Angiosarcoma Study Summary: This is a window opportunity study of propranolol in patients with angiosarcoma. The aim of this study is to prospectively evaluate the activity of propranolol in the clinical setting as monotherapy, where the neoadjuvant setting provides a good opportunity to rapidly evaluate both the clinical response and histological response, without a significant delay in anti-cancer treatment. Sponsor: The Netherlands Cancer Institute Intervention: Propranolol Start Date: 2019-12-27 Last Updated: 2023-11-22 Number of Patients: 14 Recruitment Status: COMPLETED Condition: Angiosarcoma
NCTID: NCT05270044
Title: Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Study Summary: The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance). Sponsor: Pierre Fabre Medicament Intervention: Encorafenib and Binimetinib Start Date: 2022-05-02 Last Updated: 2023-11-22 Number of Patients: 815 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT00454376
Title: Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors Study Summary: RATIONALE: Questionnaires that measure quality of life may help doctors identify the effects of treatment and improve the ability to plan treatment for patients with gastrointestinal-related neuroendocrine tumors. PURPOSE: This phase IV clinical trial is studying how well a disease-specific questionnaire works in assessing the quality of life of patients with gastrointestinal-related neuroendocrine tumors. Sponsor: National Cancer Institute (NCI) Intervention: questionnaire administration Start Date: 2006-10 Last Updated: 2013-10-29 Number of Patients: 408 Recruitment Status: UNKNOWN Condition: Gastrointestinal Carcinoid Tumor
NCTID: NCT00014274
Title: Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective for transitional cell cancer of the urothelium. PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: carboplatin Start Date: 2001-01 Last Updated: 2013-06-12 Number of Patients: 238 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT03048474
Title: Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma Study Summary: This is a prospective, monocenter, single arm, phase II trial in 33 patients with unresectable MPM, who experience disease progression or recurrence after at least one previous line of platinum-based systemic treatment. Nivolumab will be administered at a fixed dose of 240 mg every 2 week. Nivolumab will be given in combination with ipilimumab on week 1, 7, 13 and 19 and will be administered prior to the infusion of ipilimumab. Ipilimumab will be administered at the dose of 1 mg/Kg.The patients will receive nivolumab monotherapy on week 3, 5, 9, 11, 15 and 17. From week 21 thereafter, Nivolumab will be then administered every 2 weeks for a maximum period of 2 years or until disease progression or unacceptable toxicity occurs. Sponsor: The Netherlands Cancer Institute Intervention: nivolumab and ipilimumab Start Date: 2016-09 Last Updated: 2021-01-20 Number of Patients: 36 Recruitment Status: COMPLETED Condition: Malignant Pleural Mesothelioma
NCTID: NCT04449874
Title: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Study Summary: This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation. Sponsor: Genentech, Inc. Intervention: GDC-6036 Start Date: 2020-07-29 Last Updated: 2023-11-13 Number of Patients: 498 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT04998474
Title: FRAME-001 Personalized Vaccine in NSCLC Study Summary: Despite encouraging results of programmed cell death protein -1 (PD-1) immune checkpoint inhibitor treatment combined with chemotherapy in advanced non-small cell lung cancer (NSCLC), only the minority of approximately 20% of patients derive durable clinical benefit from such treatment. Patients with stable disease (SD) after four cycles of treatment with PD-1 inhibitor pembrolizumab monotherapy or in combination with chemotherapy (standard of care in advanced NSCLC in the Netherlands) have a low probability of still acquiring a complete response (CR) or durable disease control to such treatment and no other curative standard treatment options are available, emphasizing the need for novel therapeutic approaches. Tumor-specific neopeptides resulting from frameshift mutations in tumor cells, so-called Frames, present potentially potent targets for the immune system and can be utilized in therapeutic anti-cancer vaccination with the intention to synergize in their effect with immune chckpoint inhibitors. Frames are prevalent in NSCLC patients, with 95% of lung tumors harboring one or more Frames. The entire collection of Frames expressed by a tumor is referred to as the Framome. Vaccination against strongly antigenic neopeptides present in a patient’s tumor furnishes a perspective of enhancing the therapeutic effect of the immune checkpoint inhibition in NSCLC with expected limited additional toxicities. The current clinical trial is designed to determine immune response, safety, and clinical response of personalized vaccine FRAME-001 based on a patient’s Framome and selection of Frame peptides in advanced NSCLC cancer patients after standard first line treatment consisting of immune checkpoint inhibitor pembrolizumab as monotherapy or combined with chemotherapy (carboplatin/cisplatin and pemetrexed/paclitaxel), and who attained SD after four cycles of such therapy. The personalized FRAME-001 vaccine will be administered during maintenance phase of treatment with pembrolizumab monotherapy. Sponsor: Frame Pharmaceuticals B.V. Intervention: FRAME-001 personalized vaccine Start Date: 2022-01 Last Updated: 2021-08-10 Number of Patients: 15 Recruitment Status: NOT_YET_RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT02322281
Title: TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy Study Summary: The purpose of this study is to compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the PFS, with that of single-agent cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after failure of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containing doublet chemotherapy. Sponsor: Clovis Oncology, Inc. Intervention: Rociletinib Start Date: 2015-02 Last Updated: 2019-08-14 Number of Patients: 149 Recruitment Status: TERMINATED Condition: Non-small Cell Lung Cancer
NCTID: NCT01713699
Title: Circulating Tumor Cells and Cytology in Cerebrospinal Fluid of Patients Clinically Suspected for Leptomeningeal Metastases Study Summary: The purpose of this study is to determine whether the quantitative detection of circulating tumor cells (CTCs) in patients with Epcam expressing tumors can be used compared to standard qualitative method - cytology both in the cerebrospinal fluid of patients, clinically suspected for leptomeningeal metastases. Sponsor: The Netherlands Cancer Institute Intervention: lumbar puncture Start Date: 2012-09 Last Updated: 2021-01-22 Number of Patients: 146 Recruitment Status: COMPLETED Condition: Meningeal Carcinomatosis
NCTID: NCT05518799
Title: CYP3A4 Activity in Patients With Prostate Cancer Versus Male Patients With Other Solid Tumours Study Summary: The hepatic enzyme, cytochrome P450 3A4 (CYP3A4) is important for the metabolism of many drugs including taxanes. Previous reported studies reported a decreases in docetaxel exposure in prostate cancer patients compared to patients with other solid tumours. The difference was 1.8-fold for intravenous administration and 2.8-fold for oral administration. The underlying mechanism for these observations remains to be elucidated. The lower docetaxel exposure with IV and oral docetaxel treatment might be related to a higher CYP3A4 activity in prostate cancer patients. Therefore, it is important to directly compare the CYP3A4 activity with a phenotyping test in prostate cancer patients and patients with other types of solid tumours. This is an in vivo phenotyping studying using midazolam as a probe for CYP3A4 activity in patients with prostate cancer and patients with other solid tumours. The primary objective is the comparison of CYP3A4 activity in prostate cancer patients versus male patients with other types of solid tumours by use of an oral midazolam phenotyping test. Secondary objectives are: (1) measurement of plasma concentrations of midazolam and it’s two primary metabolites (1’-hydroxy midazolam and 4’-hydroxy midazolam), (2) determination of the metabolite pharmacokinetics of midazolam. (3) retrospective assessment of single nucleotide polymorphisms of CYP3A4. The exploratory objective is to differentiate between gastro-intestinal and hepatic CYP3A4 activity with oral and intravenous administration of midazolam. Sponsor: The Netherlands Cancer Institute Intervention: Midazolam Start Date: 2021-04-22 Last Updated: 2023-05-22 Number of Patients: 18 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03367780
Title: Dose-Effect Relation of Salivary Gland Irradiation Study Summary: Optimization of radiotherapy to reduce xerostomia is difficult, because many gland locations cannot be seen with current imaging modalities and biological dose-effect are currently insufficiently understood. PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal. A reduction of PSMA accumulation in salivary glands is thought to correlate with loss of vital acinar cells. The PET images can be correlated with radiotherapy dose distributions in gland-based or voxel-based evaluations. This makes PSMA PET a suitable instrument to derive the radiobiological dose-effect relations that are required to develop better and gland-specific dose constraints for radiotherapy. The results of this study can contribute to lower toxicity and better quality of life in patients treated with high-dose radiotherapy in the head and neck. Sponsor: The Netherlands Cancer Institute Intervention: PSMA PET/CT-scan Start Date: 2017-11-21 Last Updated: 2021-08-19 Number of Patients: 32 Recruitment Status: COMPLETED Condition: HNSCC
NCTID: NCT04194957
Title: Improving the Safety of Fluoropyrimidine-based Chemotherapy Study Summary: In this study it will be determined whether the rate of severe toxicity associated with fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished by individualized dosing of fluoropyrimidines based on upfront phenotypic assessment of dihydropyrimidine dehydrogenase (DPD) deficiency. Sponsor: The Netherlands Cancer Institute Intervention: Fluoropyrimidine (capecitabine or 5-fluorouracil) Start Date: 2020-01-15 Last Updated: 2020-01-22 Number of Patients: 1440 Recruitment Status: UNKNOWN Condition: Neoplasms
NCTID: NCT00025636
Title: Combination Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Relapsed Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkin’s lymphoma. Sponsor: German Hodgkin’s Lymphoma Study Group Intervention: filgrastim Start Date: 2001-07 Last Updated: 2013-09-17 Number of Patients: 220 Recruitment Status: UNKNOWN Condition: Lymphoma
NCTID: NCT03319940
Title: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) Study Summary: A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC Sponsor: Amgen Intervention: Tarlatamab Start Date: 2017-12-26 Last Updated: 2023-11-27 Number of Patients: 392 Recruitment Status: RECRUITING Condition: Small Cell Lung Carcinoma
NCTID: NCT05765734
Title: A Study of TAS3351 in NSCLC Patients With EGFRmt Study Summary: This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation. Sponsor: Taiho Oncology, Inc. Intervention: TAS3351 oral administration Start Date: 2023-05-03 Last Updated: 2023-11-21 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT01386580
Title: An Open-label, Phase I/IIa, Dose Escalating Study of 2B3-101 in Patients With Solid Tumors and Brain Metastases or Recurrent Malignant Glioma. Study Summary: The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of 2B3-101 both as single agent and in combination with trastuzumab. Furthermore, the study will explore the preliminary antitumor activity of 2B3-101 as single agent in patients with with solid tumors and brain metastases or recurrent malignant glioma as well as in patients with various forms of breast cancer with and in combination with trastuzumab in HER2+ breast cancer patients with brain metastases. Sponsor: BBB-Therapeutics B.V. Intervention: 2B3-101 Start Date: 2011-07 Last Updated: 2015-01-22 Number of Patients: 84 Recruitment Status: COMPLETED Condition: Brain Metastases
NCTID: NCT02324257
Title: A Study of RO6958688 in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen Positive Solid Tumors Study Summary: Study BP29541 is a first-in-human, open-label, multi-center, dose-escalation Phase I clinical study of single-agent RO6958688 in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA) positive solid tumors who have progressed on standard treatment, are intolerant to standard of care (SOC), and/or are non-amenable to SOC. The study will be conducted in two parts. Part I of the study will investigate the safety and pharmacokinetics of a single dose of RO6958688 in single participant cohorts with dosing starting from a minimal anticipated biological effect level dose of 0.05 milligrams (mg) and up to a maximum dose of 2.5 mg. Part II will establish the appropriate therapeutic dose based on safety, pharmacokinetics, and the maximum tolerated dose (MTD) of RO6958688 for the once per week (QW) regimen, every three weeks (Q3W) regimen, and for the step up dosing regimen. Sponsor: Hoffmann-La Roche Intervention: RO6958688 Start Date: 2014-12-30 Last Updated: 2020-04-17 Number of Patients: 149 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT02418624
Title: Phase I of Carboplatin-Olaparib Followed by Olaparib Monotherapy in Advanced Cancer Study Summary: A phase I trial to determine the recommended phase two dose of the combination of carboplatin and olaparib. Sponsor: The Netherlands Cancer Institute Intervention: carboplatin, olaparib Start Date: 2015-05 Last Updated: 2019-01-16 Number of Patients: 25 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02365441
Title: A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST) Study Summary: An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST. Sponsor: Australasian Gastro-Intestinal Trials Group Intervention: Regorafenib Start Date: 2015-06-30 Last Updated: 2023-07-07 Number of Patients: 78 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastrointestinal Stromal Tumour
NCTID: NCT03474341
Title: Preoperative Image-guided Identification of Response to Neoadjuvant Chemoradiotherapy in Esophageal Cancer Study Summary: Rationale: For locally advanced esophageal cancer the standard treatment consists of 5 weeks of neoadjuvant chemoradiotherapy (nCRT) followed by surgery. Surgery is currently performed independent of the response to nCRT and is associated with substantial morbidity. Prior knowledge of the eventual response to nCRT would greatly impact on the optimal care for many esophageal cancer patients for two imperative reasons: Firstly, it is argued that patients who achieved a pathologic complete response (pCR, 29%) may not have benefitted from surgery. Consequently, proper identification of pathological complete responders prior to surgery could yield an organ-preserving regimen avoiding unnecessary toxicity. Secondly, non-responders are exposed to the side effects of nCRT without showing any tumor regression. Early identification of the non-responders during nCRT would be beneficial for this group as ineffective therapy could be stopped, and for who altered treatment strategies could be explored. Objective: To develop a multimodal model that predicts the probability of pathologic complete response to nCRT in esophageal cancer, by integrating diffusion weighted magnetic resonance imaging (DW-MRI) and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) in conjunction with combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography (18F-FDG PET-CT) scans acquired prior to, during and after administration of nCRT. Study design: Multi-center observational study Study population: Patients (>18 years) with potentially resectable locally advanced squamous cell- or adenocarcinoma of the esophagus or gastroesophageal junction, receiving nCRT prior to surgery. Intervention: In addition to the standard diagnostic work-up for esophageal cancer that includes a 18F-FDG PET-CT scan at diagnosis and after nCRT, one 18F-FDG PET-CT scans will be performed during nCRT, as well as three MRI scans (before, during and after nCRT) within fixed time intervals. Furthermore, after response imaging after nCRT has been performed, but prior to surgery, patients will undergo (on an opt-out basis) an endoscopy and/or endoscopic ultrasonography (EUS) with biopsies of the primary tumor site, other suspected lesions and suspected lymph nodes. Furthermore, blood samples will be collected at three time points. Main study parameters/endpoints: An accurate multimodal prediction model for the patients’ individual probability of pathologic complete response after nCRT, based on the quantitative parameters derived from a longitudinal series of DW-MRI, DCE-MRI and 18F-FDG PET-CT datasets. Sponsor: UMC Utrecht Intervention: MRI Start Date: 2018-04-09 Last Updated: 2020-11-16 Number of Patients: 200 Recruitment Status: UNKNOWN Condition: Esophageal Cancer
NCTID: NCT00002641
Title: Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: filgrastim Start Date: 1995-02 Last Updated: 2014-08-08 Number of Patients: 350 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT03708211
Title: A Study to Assess the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics (PK) of TAK-931 in Participants With Advanced Solid Tumors Study Summary: The purpose of this study is to estimate the relative bioavailability of TAK-931 tablets in reference to powder-in capsule (PIC) and to assess the effect of food and esomeprazole on the pharmacokinetics (PK) of TAK-931 as a tablet. Sponsor: Millennium Pharmaceuticals, Inc. Intervention: TAK-931 PIC Start Date: 2019-03-28 Last Updated: 2020-12-29 Number of Patients: 20 Recruitment Status: COMPLETED Condition: Neoplasms, Advanced Solid
NCTID: NCT01173913
Title: Weekly Administration of (bi-)Daily Oral Docetaxel in Combination With Ritonavir Study Summary: Oral administration has many advantages above intravenously administrated drugs for patients. Up to now, oral administration of docetaxel as single agent has not been feasible due to low and variable bioavailability. This low systematic exposure to docetaxel can effectively be increased after co-administration of ritonavir. The department of pharmacy of the Slotervaart Hospital and Netherlands Cancer Institute developed a solid oral dosage form for docetaxel, ModraDoc001 10 mg capsules. Two other novel dosage forms of docetaxel with improved pharmaceutical characteristics, have been developed: ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets. The systemic exposure after administration of those forms is now being investigated. Sponsor: The Netherlands Cancer Institute Intervention: ModraDoc001 10mg capsules Start Date: 2010-09 Last Updated: 2019-01-10 Number of Patients: 57 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT00838370
Title: Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines Study Summary: The primary purpose of this study is to prospectively determine whether capecitabine and 5-FU-induced toxicity is preventable by dose reduction prior to start of the first administration in patients heterozygous or homozygous mutant for DPYD*2A, and to determine whether this strategy is cost-effective. Secondly, an individualized treatment algorithm for capecitabine and 5-FU therapy in DPYD*2A mutant patients will be developed and the pharmacokinetic profile of capecitabine and 5-FU will be assessed. Sponsor: The Netherlands Cancer Institute Intervention: Capecitabine, 5-fluorouracil Start Date: 2007-05 Last Updated: 2014-03-04 Number of Patients: 22 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT01818713
Title: Clinical and Pharmacological Study With 2B3-101 in Patients With Breast Cancer and Leptomeningeal Metastases Study Summary: Leptomeningeal metastases (LM) develop when tumor cells reach the cerebrospinal fluid (CSF) and infiltrate the leptomeninges. The median survival of patient with breast cancer and LM is 4-6 months with up to 25% long-term survivors. Many potentially highly efficacious intravenous chemotherapies are currently not effective to treat LM because they do not adequately cross the blood-CSF barrier. Doxorubicin, the anthracycline chemotherapeutic agent, has a well-established antineoplastic activity in breast cancer. To optimally enhance the delivery of liposomal doxorubicin to the brain, to-BBB technologies B.V. has designed a glutathione (GSH) pegylated liposomal doxorubicin hydrochloride formulation (2B3-101). Coating of liposomes with PEG ensures the prolonged circulation time in plasma, whilst conjugation of GSH to the tips of the PEG molecules targets the liposomes towards the active GSH transporters on the BBB to enhance the delivery of doxorubicin to the brain. This is a a clinical and pharmacological study that aims to determine preliminary efficacy of treatment with 2B3-101 in patients with leptomeningeal metastases of breast cancer using the LM response score. Sponsor: The Netherlands Cancer Institute Intervention: 2B3-101 Start Date: 2013-10 Last Updated: 2013-10-29 Number of Patients: 6 Recruitment Status: UNKNOWN Condition: Meningeal Carcinomatosis
NCTID: NCT03784599
Title: T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC Study Summary: This is a single arm open-label multi-center phase II study, investigating disease control rate after 3 months of treatment with trastuzumab-emtansine/osimertinib combination therapy in patients with advanced EGFR mutation positive non-small cell lung cancer (NSCLC) with HER2 bypass track resistance. Sponsor: The Netherlands Cancer Institute Intervention: Trastuzumab emtansine Start Date: 2018-12-18 Last Updated: 2022-11-10 Number of Patients: 28 Recruitment Status: TERMINATED Condition: Carcinoma, Non-Small-Cell Lung
