Trials (Léon Bérard Center)
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NCTID: NCT01222767
Title: Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy Study Summary: This is a phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis® (PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy to determine the antitumor activity of Zalypsis. Sponsor: PharmaMar Intervention: Zalypsis Start Date: 2010-12 Last Updated: 2021-10-29 Number of Patients: 17 Recruitment Status: COMPLETED Condition: Ewing’s Sarcoma
NCTID: NCT01798485
Title: A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC Study Summary: The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer. Sponsor: Synta Pharmaceuticals Corp. Intervention: Docetaxel Start Date: 2013-04 Last Updated: 2016-07-01 Number of Patients: 696 Recruitment Status: TERMINATED Condition: Non-Small-Cell Lung Adenocarcinoma
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: NCT03336333
Title: A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL Study Summary: To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review. Sponsor: BeiGene Intervention: Zanubrutinib Start Date: 2017-10-31 Last Updated: 2023-11-09 Number of Patients: 590 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT01882933
Title: D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma Study Summary: A prospective, opened, multicentric, randomised, phase III trial with two arms: * Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin * Arm B: curative gastrectomy with D1-D2 lymph node dissection Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone. Sponsor: Hospices Civils de Lyon Intervention: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin Start Date: 2013-06 Last Updated: 2023-04-19 Number of Patients: 367 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastric Adenocarcinoma
NCTID: NCT03038100
Title: A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study Summary: This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery. Sponsor: Hoffmann-La Roche Intervention: Paclitaxel Start Date: 2017-03-08 Last Updated: 2023-02-17 Number of Patients: 1301 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT02500043
Title: Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer Study Summary: The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer. Sponsor: Taiho Oncology, Inc. Intervention: TAS-102 Start Date: 2016-02-24 Last Updated: 2021-09-16 Number of Patients: 507 Recruitment Status: COMPLETED Condition: Refractory Metastatic Gastric Cancer
NCTID: NCT02947685
Title: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer Study Summary: The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer. Sponsor: Alliance Foundation Trials, LLC. Intervention: palbociclib Start Date: 2017-06-21 Last Updated: 2023-05-30 Number of Patients: 496 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: HER-2 Positive Breast Cancer
NCTID: NCT03940703
Title: A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2) Study Summary: This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Tepotinib Start Date: 2019-09-19 Last Updated: 2023-08-29 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT01322490
Title: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer Study Summary: The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer. Sponsor: Bavarian Nordic Intervention: PROSTVAC-V Start Date: 2011-11-28 Last Updated: 2019-09-04 Number of Patients: 1297 Recruitment Status: COMPLETED Condition: Prostate Cancer Metastatic
NCTID: NCT03493854
Title: A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer Study Summary: This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting. Sponsor: Hoffmann-La Roche Intervention: Cyclophosphamide Start Date: 2018-06-14 Last Updated: 2023-06-15 Number of Patients: 500 Recruitment Status: COMPLETED Condition: Early Breast Cancer
NCTID: NCT04704154
Title: A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors Study Summary: Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts. The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion). The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years. During the trial, the doctors will take pictures of the participants’ tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants’ heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems. Sponsor: Bayer Intervention: Regorafenib, (Stivarga, BAY73-4506) Start Date: 2021-02-03 Last Updated: 2023-11-28 Number of Patients: 175 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors
NCTID: NCT03520075
Title: Study of ASTX029 in Subjects With Advanced Solid Tumors Study Summary: This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to subjects with advanced solid malignancies who are not candidates for approved or available therapies. Sponsor: Astex Pharmaceuticals, Inc. Intervention: ASTX029 Start Date: 2018-05-10 Last Updated: 2023-08-04 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Solid Tumor, Adult
NCTID: NCT02098343
Title: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 Study Summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients. Sponsor: Aprea Therapeutics Intervention: APR-246 Start Date: 2014-03 Last Updated: 2022-10-13 Number of Patients: 247 Recruitment Status: COMPLETED Condition: Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53
NCTID: NCT04197986
Title: Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations Study Summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer. Sponsor: QED Therapeutics, Inc. Intervention: Infigratinib Start Date: 2020-03-11 Last Updated: 2023-02-02 Number of Patients: 39 Recruitment Status: TERMINATED Condition: Upper Tract Urothelial Carcinomas
NCTID: NCT04300556
Title: A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types Study Summary: The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer <math display="block">OC</math>, endometrial cancer <math display="block">EC</math>, non-small cell lung carcinoma <math display="block">NSCLC</math>, triple-negative breast cancer <math display="block">TNBC</math>), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A <math display="block">OC and EC participants</math> and Part B <math display="block">EC only</math>): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202). Sponsor: Eisai Inc. Intervention: Farletuzumab ecteribulin Start Date: 2020-08-06 Last Updated: 2023-11-01 Number of Patients: 142 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT01956812
Title: Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer Study Summary: The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen). Sponsor: Gilead Sciences Intervention: IMMU-107 Start Date: 2013-12 Last Updated: 2021-08-16 Number of Patients: 334 Recruitment Status: TERMINATED Condition: Metastatic Pancreatic Cancer
NCTID: NCT04597125
Title: Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH Study Summary: Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain. Sponsor: Bayer Intervention: Radium-223 dichloride (Xofigo, BAY88-8223) Start Date: 2020-11-09 Last Updated: 2023-11-14 Number of Patients: 696 Recruitment Status: RECRUITING Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC)
NCTID: NCT01578655
Title: Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer Study Summary: This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms. Sponsor: Achieve Life Sciences Intervention: cabazitaxel Start Date: 2012-08 Last Updated: 2016-10-12 Number of Patients: 630 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT00789633
Title: Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer Study Summary: The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer. Sponsor: AB Science Intervention: Masitinib Start Date: 2008-11-25 Last Updated: 2018-12-17 Number of Patients: 353 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT02438007
Title: A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC Study Summary: The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC). Sponsor: LTN PHARMACEUTICALS, INC. Intervention: Galeterone Start Date: 2015-06 Last Updated: 2023-03-15 Number of Patients: 953 Recruitment Status: TERMINATED Condition: Prostate Cancer
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: NCT02471716
Title: Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor Study Summary: This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients. Sponsor: Five Prime Therapeutics, Inc. Intervention: FPA008 Start Date: 2015-06 Last Updated: 2021-08-31 Number of Patients: 66 Recruitment Status: COMPLETED Condition: Pigmented Villonodular Synovitis
NCTID: NCT02983045
Title: A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors Study Summary: In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3. Sponsor: Nektar Therapeutics Intervention: Dose Escalation Doublet: Combination of NKTR-214 + nivolumab Start Date: 2016-12-19 Last Updated: 2023-03-13 Number of Patients: 557 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT03485209
Title: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors Study Summary: This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study. * In Part A, the treatment will be given to participants every 3 weeks (3-week cycles). * In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle. * In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either: ** Pembrolizumab or, ** Pembrolizumab and carboplatin, or ** Pembrolizumab and cisplatin * In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab. * In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin. Sponsor: Seagen Inc. Intervention: tisotumab vedotin Start Date: 2018-06-25 Last Updated: 2023-11-14 Number of Patients: 692 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms
NCTID: NCT04901806
Title: Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors Study Summary: This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors. Sponsor: Pyramid Biosciences Intervention: PBI-200 Start Date: 2021-07-20 Last Updated: 2023-05-11 Number of Patients: 74 Recruitment Status: RECRUITING Condition: Solid Tumor, Adult
NCTID: NCT00312845
Title: Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma Study Summary: The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below. Sponsor: Millennium Pharmaceuticals, Inc. Intervention: Bortezomib + Rituximab Start Date: 2006-03 Last Updated: 2012-06-25 Number of Patients: 676 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphoma
NCTID: NCT01310816
Title: A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma Study Summary: IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma. Sponsor: Infinity Pharmaceuticals, Inc. Intervention: IPI-926 Start Date: 2011-02 Last Updated: 2013-12-05 Number of Patients: 105 Recruitment Status: COMPLETED Condition: Conventional Chondrosarcoma
NCTID: NCT00069745
Title: Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen Study Summary: PURPOSE: The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC). TARGET PATIENT POPULATION: The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria. WHAT IS SATRAPLATIN: Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial. RATIONALE: There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy Sponsor: Agennix Intervention: Satraplatin Start Date: 2003-09 Last Updated: 2012-08-07 Number of Patients: NA Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT02730416
Title: Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer Study Summary: This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer. Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit Intervention: Nintedanib or Placebo; Carboplatin, Paclitaxel Start Date: 2016-12-12 Last Updated: 2023-09-21 Number of Patients: 146 Recruitment Status: COMPLETED Condition: Endometrial 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: NCT02383927
Title: Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations Study Summary: Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available. Note; Only cohort 2 (Head & Neck SCC) and cohort 3 (Other SCC) are currently open Sponsor: Kura Oncology, Inc. Intervention: Tipifarnib Start Date: 2015-03 Last Updated: 2021-05-14 Number of Patients: 63 Recruitment Status: COMPLETED Condition: Thyroid Cancer
NCTID: NCT03424005
Title: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer Study Summary: This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line <math display="block">1L</math> PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line <math display="block">2L</math> CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment. Sponsor: Hoffmann-La Roche Intervention: Capecitabine Start Date: 2018-04-02 Last Updated: 2023-11-07 Number of Patients: 242 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT01732926
Title: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Study Summary: The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2013-01-02 Last Updated: 2018-11-16 Number of Patients: 475 Recruitment Status: TERMINATED Condition: Indolent Non-Hodgkin’s Lymphomas
NCTID: NCT03456063
Title: A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030) Study Summary: This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2018-04-24 Last Updated: 2023-10-27 Number of Patients: 453 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small-Cell Lung
NCTID: NCT03410693
Title: Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma Study Summary: This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied. Sponsor: Bayer Intervention: Rogaratinib (BAY1163877) Start Date: 2018-05-31 Last Updated: 2022-09-28 Number of Patients: 175 Recruitment Status: COMPLETED Condition: Carcinoma, Transitional Cell
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: NCT03136627
Title: Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC Study Summary: This study will evaluate the safety, tolerability, dose-limiting toxicities, MTD, and preliminary anti-tumor activity of tivozanib in combination with nivolumab in subjects with metastatic renal cell cancer. This will use a standard ‘3+3’ dose-escalation trial design. A cohort of 3 subjects will be enrolled at each dose level. If 1 of 3 subjects experiences a DLT during Cycle 1, that dose level will be expanded to 6 subjects. If 0 of 3 or ≤ 1 of 6 subjects experience a DLT during Cycle 1, escalation to the next dose will occur. If ≥ 2 of 6 subjects experience a DLT during Cycle 1, dose escalation will stop and the prior dose will be considered the MTD. This is a validated trial design for Phase 1 trials. Following completion of the dose-escalation cohorts and determination of MTD, an expansion cohort of up to 20 subjects may be enrolled at MTD to further evaluate safety, tolerability, and preliminary anti-tumor activity of tivozanib in combination with nivolumab in the same target population. Sponsor: AVEO Pharmaceuticals, Inc. Intervention: Tivozanib Start Date: 2017-03-22 Last Updated: 2021-12-06 Number of Patients: 28 Recruitment Status: COMPLETED Condition: Carcinoma, Renal Cell
NCTID: NCT05002127
Title: A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) Study Summary: A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma. Sponsor: ALX Oncology Inc. Intervention: Evorpacept (ALX148) Start Date: 2022-01-15 Last Updated: 2023-01-25 Number of Patients: 450 Recruitment Status: RECRUITING Condition: Gastric Cancer
NCTID: NCT03178552
Title: A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) Study Summary: This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays. Sponsor: Hoffmann-La Roche Intervention: Alectinib Start Date: 2017-09-22 Last Updated: 2023-11-03 Number of Patients: 1000 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT01792726
Title: A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer. Study Summary: TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial. Eligible patients are those with a higher risk of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually. The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life. Sponsor: University College, London Intervention: Boost to the tumour bed Start Date: 2013-06 Last Updated: 2019-07-12 Number of Patients: 1796 Recruitment Status: UNKNOWN Condition: Early Breast Cancer
NCTID: NCT00083304
Title: Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer Study Summary: RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy. RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better. This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place. Sponsor: Spectrum Pharmaceuticals, Inc Intervention: Efaproxiral Start Date: 2004-02 Last Updated: 2013-05-10 Number of Patients: 368 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04675827
Title: De-escalation Adjuvant Chemo in HER2+/ER-
ode-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade
Study Summary: DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator’s discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator’s discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment). Sponsor: Jules Bordet Institute Intervention: Pertuzumab and tratuzumab fixed dose combination Start Date: 2022-01-17 Last Updated: 2023-09-05 Number of Patients: 1065 Recruitment Status: SUSPENDED Condition: HER2-positive Breast Cancer
NCTID: NCT03428217
Title: CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma Study Summary: Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC). Sponsor: Calithera Biosciences, Inc Intervention: CB-839 Start Date: 2018-04-24 Last Updated: 2023-03-20 Number of Patients: 444 Recruitment Status: COMPLETED Condition: Advanced Renal Cell Carcinoma
NCTID: NCT05462717
Title: Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors Study Summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose. Sponsor: Revolution Medicines, Inc. Intervention: RMC-6291 Start Date: 2022-09-19 Last Updated: 2023-10-18 Number of Patients: 117 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer (NSCLC)
NCTID: NCT03780517
Title: Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors Study Summary: This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738. Sponsor: Boston Pharmaceuticals Intervention: BOS172738 Start Date: 2018-12-12 Last Updated: 2023-10-30 Number of Patients: 117 Recruitment Status: COMPLETED Condition: Advanced Nonhaematologic Malignancies
NCTID: NCT04187404
Title: A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma Study Summary: This is a multicenter, Phase 1/2, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma. Sponsor: Enterome Intervention: EO2401 Start Date: 2020-07-23 Last Updated: 2023-08-25 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Adrenocortical Carcinoma
NCTID: NCT03941093
Title: Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced Pancreatic Cancer Study Summary: This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G
P) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer.
Sponsor: FibroGen Intervention: Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX Start Date: 2019-05-10 Last Updated: 2022-12-27 Number of Patients: 284 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Pancreatic Cancer Non-resectable
NCTID: NCT03102320
Title: Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors Study Summary: The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor’s objective response rate. Radiological tumor assessments will be performed at defined time points until the patient’s disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses. Sponsor: Bayer Intervention: Cisplatin Start Date: 2017-05-26 Last Updated: 2022-06-30 Number of Patients: 173 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT00910091
Title: The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer Study Summary: This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA) on progression free survival (PFS) in post menopausal patients with endometrial cancer. Sponsor: Ipsen Intervention: BN83495 Start Date: 2009-08 Last Updated: 2019-01-30 Number of Patients: 73 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT03377491
Title: Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3) Study Summary: Brief Summary: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. Sponsor: NovoCure Ltd. Intervention: NovoTTF-200T Start Date: 2018-02-10 Last Updated: 2023-04-10 Number of Patients: 556 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Pancreas Adenocarcinoma
NCTID: NCT02292979
Title: Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma. Study Summary: This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy. Sponsor: The Lymphoma Academic Research Organisation Intervention: Doxorubicin Start Date: 2015-03 Last Updated: 2022-08-19 Number of Patients: 170 Recruitment Status: COMPLETED Condition: Hodgkin Lymphoma
NCTID: NCT03978039
Title: National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group Study Summary: The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas <math display="block">RESOS</math> / French expert network dedicated to the pathology of sarcomas <math display="block">RREPS</math>), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS / French expert clinical network for sarcomas <math display="block">NETSARC</math>), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE / BONE / GIST) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples. Primary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients’ outcomes. With the financial support of the French National Cancer Institute <math display="block">Institut National du cancer \[INCa</math>). Sponsor: Institut Bergonié Intervention: Chemotherapy Start Date: 2010-01 Last Updated: 2023-07-05 Number of Patients: 20000 Recruitment Status: RECRUITING Condition: Sarcoma
NCTID: NCT02360579
Title: Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma Study Summary: Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen. Sponsor: Iovance Biotherapeutics, Inc. Intervention: Lifileucel Start Date: 2015-09 Last Updated: 2023-07-12 Number of Patients: 178 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Melanoma
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: NCT03906071
Title: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer Study Summary: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy. Sponsor: Mirati Therapeutics Inc. Intervention: Nivolumab Start Date: 2019-07-15 Last Updated: 2023-10-24 Number of Patients: 532 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non-Squamous Non-Small Cell Lung Cancer
NCTID: NCT03556839
Title: Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix Study Summary: The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity. The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin). This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment. Sponsor: Grupo Español de Investigación en Cáncer de Ovario Intervention: Atezolizumab Start Date: 2018-09-25 Last Updated: 2023-09-13 Number of Patients: 404 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma of the Cervix, Stage IVB
NCTID: NCT02794571
Title: Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors Study Summary: This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with atezolizumab and/or other anti-cancer therapies in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care. Sponsor: Genentech, Inc. Intervention: Atezolizumab Start Date: 2016-05-23 Last Updated: 2023-09-13 Number of Patients: 518 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced/Metastatic Tumors
NCTID: NCT01802749
Title: Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer Study Summary: Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone. Sponsor: National Cancer Institute, Naples Intervention: Bevacizumab Start Date: 2013-11 Last Updated: 2023-03-24 Number of Patients: 406 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Recurrent Ovarian Cancer
NCTID: NCT03395197
Title: Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC Study Summary: This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide. Sponsor: Pfizer Intervention: Talazoparib with enzalutamide Start Date: 2017-12-18 Last Updated: 2023-08-02 Number of Patients: 1125 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: mCRPC
NCTID: NCT01556490
Title: Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer Study Summary: The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere. Sponsor: Boston Scientific Corporation Intervention: TheraSphere Start Date: 2012-03 Last Updated: 2023-11-08 Number of Patients: 526 Recruitment Status: COMPLETED Condition: Unresectable Hepatocellular Carcinoma
NCTID: NCT05323656
Title: A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) Study Summary: The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab. Sponsor: Calliditas Therapeutics Suisse SA Intervention: Setanaxib Start Date: 2022-04-06 Last Updated: 2023-08-31 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT03108495
Title: Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma Study Summary: Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma Sponsor: Iovance Biotherapeutics, Inc. Intervention: LN-145 Start Date: 2017-06-22 Last Updated: 2023-09-13 Number of Patients: 189 Recruitment Status: RECRUITING Condition: Cervical Carcinoma
NCTID: NCT02668653
Title: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) Study Summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Chemotherapy Start Date: 2016-09-01 Last Updated: 2023-11-18 Number of Patients: 539 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT03353753
Title: Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies Study Summary: This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo Sponsor: Deciphera Pharmaceuticals LLC Intervention: DCC-2618 Start Date: 2018-02-27 Last Updated: 2022-11-21 Number of Patients: 129 Recruitment Status: COMPLETED Condition: Gastrointestinal Stromal Tumors
NCTID: NCT05059262
Title: Study of Vimseltinib for Tenosynovial Giant Cell Tumor Study Summary: This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib. Sponsor: Deciphera Pharmaceuticals LLC Intervention: vimseltinib Start Date: 2021-10-14 Last Updated: 2023-03-16 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Tenosynovial Giant Cell Tumor
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: NCT03872947
Title: A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors Study Summary: The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, Gemcitabine / Carboplatin / Bevacizumab, Topotecan, and Pegylated liposomal doxorubicin (PLD) for selected advanced solid tumors. Sponsor: Toray Industries, Inc Intervention: TRK-950 Start Date: 2019-04-26 Last Updated: 2023-11-18 Number of Patients: 169 Recruitment Status: RECRUITING Condition: Solid Tumor
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: NCT00430365
Title: Maintenance Therapy Using Lenalidomide in Myeloma Study Summary: Maintenance treatment of myeloma. Sponsor: University Hospital, Toulouse Intervention: lenalidomide Start Date: 2006-06 Last Updated: 2019-04-26 Number of Patients: 614 Recruitment Status: COMPLETED Condition: Myeloma
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: NCT02083653
Title: Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer Study Summary: This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs). Sponsor: Symphogen A/S Intervention: Sym004 (12 mg/kg) Start Date: 2014-03-06 Last Updated: 2019-04-16 Number of Patients: 254 Recruitment Status: COMPLETED Condition: Metastatic Colorectal Cancer
NCTID: NCT01485861
Title: Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy Study Summary: This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone. Sponsor: Genentech, Inc. Intervention: Abiraterone Start Date: 2012-01-11 Last Updated: 2023-09-14 Number of Patients: 298 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT05459129
Title: A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer) Study Summary: This is a Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with locally advanced squamous cell carcinoma of the head and neck (SCCHN). The study will enroll treatment-naive participants with resectable Stage III-IVA human papillomavirus (HPV)-negative, programmed death-ligand 1 (PD-L1)-positive SCCHN with measurable disease, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) who have not received systemic treatment for their disease. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2023-04-13 Last Updated: 2023-11-07 Number of Patients: 90 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT01739764
Title: An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol Study Summary: This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol’s criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first. Sponsor: Hoffmann-La Roche Intervention: Vemurafenib Start Date: 2013-02-19 Last Updated: 2021-01-07 Number of Patients: 215 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT04921553
Title: Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING) Study Summary: This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion. This TRacKING registry is a European collaborative tool to improve the management of patients with actionable fusions, by sharing of data from rare tumor indications. Sponsor: Centre Leon Berard Intervention: Data collection and quality of life questionnaire Start Date: 2021-06-22 Last Updated: 2021-08-02 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT01909453
Title: Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma Study Summary: This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: # LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or # vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: # LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) Sponsor: Pfizer Intervention: LGX818 Start Date: 2013-12-13 Last Updated: 2023-09-07 Number of Patients: 921 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT05330429
Title: Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC) Study Summary: The goals of this clinical study are to learn more about the safety, tolerability and effectiveness of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC). The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC). Sponsor: Gilead Sciences Intervention: Magrolimab Start Date: 2022-07-08 Last Updated: 2023-11-02 Number of Patients: 135 Recruitment Status: RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT01261429
Title: Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT) Study Summary: The purpose of this study is to explore the efficacy of nilotinib as a treatment of patients with progressive or relapsing pigmented villo-nodular synovitis / tenosynovial giant cell tumour (PVNS/TGCT) who cannot be treated by surgery. The primary objective of the study will be to determine the efficacy of 12 weeks (3 months) of nilotinib treatment as measured by the non progression rate (Complete response + Partial Response + Stable disease according to Response Evaluation Criteria In Solid Tumours - RECIST version 1.1) in patients with progressive or relapsing PVNS/TGCT who cannot be treated by surgery. this study is an international, multicentre, non-randomized, open-label phase II clinical trial with a Bayesian design. A maximum sample size of 50 patients will be included in the study Sponsor: Centre Leon Berard Intervention: Tasigna Start Date: 2010-12 Last Updated: 2013-04-16 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Pigmented Villonodular Synovitis
NCTID: NCT01743469
Title: A Study With Tasquinimod Treating Patients With Hepatocellular, Ovarian, Renal Cell and Gastric Cancers Study Summary: This was an exploratory proof of concept study to determine the clinical activity of tasquinimod in patients with advanced or metastatic hepatocellular carcinoma, ovarian carcinoma, renal cell carcinoma and gastric carcinoma who had progressed after standard therapies. Sponsor: Ipsen Intervention: Tasquinimod Start Date: 2012-12 Last Updated: 2019-01-08 Number of Patients: 201 Recruitment Status: COMPLETED Condition: Advanced or Metastatic Hepatocellular Cancer
NCTID: NCT03850535
Title: A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission Study Summary: This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML). Sponsor: Hoffmann-La Roche Intervention: Idasanutlin Start Date: 2019-03-25 Last Updated: 2022-06-21 Number of Patients: 24 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
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: NCT01991210
Title: A Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin (PLD) in Participants With Platinum-Resistant Ovarian Cancer (PROC) Study Summary: This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A 2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per meter-squared (mg/m^2) IV every 4 weeks. Sponsor: Genentech, Inc. Intervention: DNIB0600A Start Date: 2014-02-06 Last Updated: 2017-08-21 Number of Patients: 95 Recruitment Status: TERMINATED Condition: Ovarian Cancer
NCTID: NCT03970746
Title: Safety, Immunogenicity and Preliminary Clinical Activity Study of PDClung01 Cancer Vaccine in NSCLC Study Summary: PDC-LUNG-101 trial is an open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer. Sponsor: PDCline Pharma SAS Intervention: PDC*lung01 Start Date: 2019-09-10 Last Updated: 2023-10-24 Number of Patients: 73 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT04246489
Title: Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer Study Summary: The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Bintrafusp alfa Start Date: 2020-03-30 Last Updated: 2023-10-23 Number of Patients: 146 Recruitment Status: COMPLETED Condition: Uterine Cervical Neoplasms
NCTID: NCT00924989
Title: A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma Study Summary: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens Sponsor: Astellas Pharma Inc Intervention: OSI-906 Start Date: 2009-12-01 Last Updated: 2018-09-05 Number of Patients: 139 Recruitment Status: COMPLETED Condition: Adrenocortical Carcinoma
NCTID: NCT02348489
Title: SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction Study Summary: To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy. Sponsor: Astex Pharmaceuticals, Inc. Intervention: SGI-110 (guadecitabine) Start Date: 2015-03-19 Last Updated: 2021-01-14 Number of Patients: 815 Recruitment Status: COMPLETED Condition: Leukemia, Myeloid, Acute
NCTID: NCT04892173
Title: NBTXR3 With or Without Cetuximab in LA-HNSCC Study Summary: This is a global, open-label, randomized, 2-arm, Investigator’s choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC. Sponsor: Nanobiotix Intervention: NBTXR3 Start Date: 2022-01-05 Last Updated: 2023-01-03 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Locally Advanced Head and Neck Squamous Cell Carcinoma
NCTID: NCT03945773
Title: Study of Cabozantinib as 2nd Line Treatment in Subjects With Locally Advanced or Metastatic Renal Cell Carcinoma (RCC) With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors Study Summary: The overall objective of this study is to evaluate the efficacy and safety of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic RCC with a clear-cell component, who progressed after prior Checkpoint Inhibitors (CPI) therapy with ipilimumab and nivolumab in combination or CPI combined with Vascular Endothelial Growth Factor (VEGF)-targeted therapy. Sponsor: Ipsen Intervention: Cabozantinib Start Date: 2020-01-08 Last Updated: 2023-10-26 Number of Patients: 127 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced or Metastatic Renal Cell Carcinoma
NCTID: NCT05389462
Title: A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors Study Summary: The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine. Sponsor: ADC Therapeutics S.A. Intervention: ADCT-601 Start Date: 2022-07-13 Last Updated: 2023-10-05 Number of Patients: 196 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT01122472
Title: Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP Study Summary: This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant. Sponsor: The Lymphoma Academic Research Organisation Intervention: Lenalidomide Start Date: 2009-04 Last Updated: 2021-07-26 Number of Patients: 650 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT03134638
Title: A Study of SY-1365 in Adult Patients With Advanced Solid Tumors Study Summary: This study consists of two parts. Part 1 is a dose-escalation/safety evaluation to provisionally identify a dose and regimen of SY-1365 for further evaluation in Part 2. Following the identification of a recommended dose and regimen from Part 1, the study entered Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients with select solid tumors, and to confirm target engagement and downstream pathway impact in patients with any solid tumor histology. Sponsor: Syros Pharmaceuticals Intervention: SY-1365 (Part 1) Start Date: 2017-05-12 Last Updated: 2021-03-09 Number of Patients: 107 Recruitment Status: TERMINATED Condition: Advanced Solid Tumors
NCTID: NCT04887831
Title: Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab Study Summary: This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in patients receiving first-line treatment for advanced/metastatic bladder cancer. Sponsor: G1 Therapeutics, Inc. Intervention: Trilaciclib Start Date: 2021-06-04 Last Updated: 2023-09-13 Number of Patients: 92 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT01373710
Title: Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis Study Summary: The purpose of this study is: Phase I: To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated by intrathecal or intraventricular route to reach a intra CSF target concentration (30 µg/mL) near the conventional therapeutic concentration and depending on the dose-limiting toxicity (DLT) Phase II: Determination of antitumor activity trastuzumab when administrated by IT or intra-ventricular in terms of neurological progression-free survival at 2 months Sponsor: Institut Curie Intervention: Trastuzumab Start Date: 2011-05-19 Last Updated: 2019-07-10 Number of Patients: 34 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT03767348
Title: Study of RP1 Monotherapy and RP1 in Combination With Nivolumab Study Summary: RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy. Sponsor: Replimune Inc. Intervention: RP1 Start Date: 2017-09-20 Last Updated: 2023-08-02 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT05329766
Title: A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies Study Summary: This is a Phase 2, open-label, parallel 3-cohort, multicenter study to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil). Sponsor: Arcus Biosciences, Inc. Intervention: Domvanalimab Start Date: 2022-06-10 Last Updated: 2023-08-31 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Gastrointestinal Tract Malignancies
NCTID: NCT02420821
Title: A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC) Study Summary: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2015-05-20 Last Updated: 2023-01-30 Number of Patients: 915 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT00873119
Title: Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary Study Summary: The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary. Sponsor: Onxeo Intervention: belinostat, carboplatin, paclitaxel Start Date: 2009-02 Last Updated: 2015-07-28 Number of Patients: 89 Recruitment Status: COMPLETED Condition: Carcinoma of Unknown Primary
NCTID: NCT03436485
Title: Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer Study Summary: The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer. Sponsor: Orion Corporation, Orion Pharma Intervention: ODM-208 Start Date: 2018-03-19 Last Updated: 2023-03-23 Number of Patients: 192 Recruitment Status: RECRUITING Condition: Prostate Cancer Metastatic
NCTID: NCT01997333
Title: Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer Study Summary: The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population. Sponsor: Celldex Therapeutics Intervention: CDX-011 Start Date: 2013-11 Last Updated: 2019-03-08 Number of Patients: 327 Recruitment Status: COMPLETED Condition: Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
NCTID: NCT05099172
Title: First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) Study Summary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. Two mutations observed in NSCLC are called EGFR- or HER2exon20ins and EGFR C797X. The study treatment, BAY2927088, works by blocking the mutated EGFR protein and also its ex20ins version which are present in NSCLC. It is also believed to work against HER2 and HER2ex20ins mutations. Researchers think this may help stop the further spread of NSCLC cancer. This is the first time that researchers will study BAY2927088 in humans. In this study, the researchers want to learn more about using BAY2927088 in participants who have NSCLC with EGFR and/or HER2 mutations including EGFRex20ins and/or HER2ex20ins mutations. The main aims of this study are to find for BAY2927088 * how safe BAY2927088 is * how it affects the body (also referred to as tolerability) * how BAY2927088 moves into, through and out of the body * the maximum amount of BAY2927088 that the participants can take without too many side effects. The researchers will also study the action of BAY2927088 against the cancer. The study will have three parts: Dose Escalation, Backfill, and Dose Expansion. Each participant of the first, so called dose escalation part, will be assigned to one of specific sequential dose groups for BAY2927088. The amount of BAY2927088 that is given increases stepwise from one group to the next. The second may be initiated at any dose that has already been tested during the first part and found to be safe and to have either reached a predicted efficacious exposure range or to have induced an objective response. The first part and second part will run concurrently. The participants of the third, so called dose expansion part, will receive the most appropriate dose of BAY2927088 found in the first and second parts. The third part may be initiated in parallel with the first and second part based on emerging data. During the study, the participants will take the study treatment in 3 week periods called “cycles”. They will in general take BAY2927088 once daily until their cancer gets worse, until they have medical problems, until they leave the study or until the study is terminated. Participants will have around 5 visits in each cycle. During the study, the study team will: * take blood and urine samples * take regular CT or MRI scans to check if the participants’ cancer has gotten better or worse * check the participants’ overall health and heart health * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. Sponsor: Bayer Intervention: BAY2927088_formulation A Start Date: 2021-10-25 Last Updated: 2023-11-28 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Advanced Non-small Cell Lung Cancer
NCTID: NCT03063762
Title: Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC) Study Summary: This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of RO6874281 in combination with atezolizumab with/without bevacizumab in participants with unresectable advanced and/or metastatic RCC. The study will consist of a dose-escalation part and an extension part. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-03-20 Last Updated: 2023-02-17 Number of Patients: 69 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT02678572
Title: Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma Study Summary: This study will evaluate patients who have melanoma that has spread from the eye to the liver: Patients in the study will be treated with Melphalan/HDS up to 6 total treatment, and will be followed until death. This study will evaluate the safety and effects of the treatment on how long patients live and how long it takes for the cancer to advance or respond to the treatment. Sponsor: Delcath Systems Inc. Intervention: Melphalan/HDS Start Date: 2016-02-01 Last Updated: 2023-04-03 Number of Patients: 102 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma, Ocular
NCTID: NCT02541604
Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors Study Summary: This early phase, multicenter, open-label, single-arm study evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of atezolizumab in pediatric and young adult participants with solid tumors for which prior treatment was proven to be ineffective. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2015-11-30 Last Updated: 2020-02-25 Number of Patients: 87 Recruitment Status: TERMINATED Condition: Solid Tumor
NCTID: NCT01772004
Title: Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) Study Summary: This is a Phase 1, open-label, dose-escalation trial of avelumab <math display="block">antibody targeting programmed death ligand 1 (anti PD-L1)</math> with consecutive parallel group expansion in participants with selected tumor indications. New recruitment is open for all active cohorts. Active cohorts: Escalation revised dosing regimen cohort. Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase . Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2013-01-31 Last Updated: 2021-12-20 Number of Patients: 1756 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT02629692
Title: Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies Study Summary: Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML Sponsor: Sun Pharma Advanced Research Company Limited Intervention: Vodobatinib (K0706) capsules Start Date: 2017-04-25 Last Updated: 2023-10-27 Number of Patients: 122 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Healthy (For Part A)
NCTID: NCT03525392
Title: Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1. Study Summary: This study was being conducted to advance new treatment for patients with metastatic or locally advanced cancers expressing Neurotensin receptor 1 (NTSR1). This study was a first administration of a radioactive drug called 177Lu-3BP-227 to patients under controlled conditions of a clinical study. The purpose of this study is to evaluate how safe this investigational drug is as well to verify how well it is tolerated by patients after several intravenous administrations. In addition, the effect of the study drug on tumoral lesions and how it distributes throughout the body and at which rate it is removed from the body was evaluated. Since 177Lu-3BP-227 is a radio-labelled drug, it will also be measured how the emitted radiation is distributed throughout the body (dosimetry). The study consisted of a phase I dose escalation part. The study originally planned to include a phase II study however due to early termination (not due to safety concerns) the study did not progress to phase II and was stopped during phase I. For the phase I dose escalation part, it was anticipated that approximately 30 subjects will be included, in up to six escalation steps. No expansion cohorts were implemented. Sponsor: Ipsen Intervention: 177Lu-3BP-227 (also called 177Lu-IPN01087) Start Date: 2018-05-03 Last Updated: 2021-06-07 Number of Patients: 14 Recruitment Status: TERMINATED Condition: Pancreatic Ductal Adenocarcinoma
NCTID: NCT02052778
Title: A Study of TAS-120 in Patients With Advanced Solid Tumors Study Summary: This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts: # Dose escalation portion to determine the MTD and/ or RP2D of futibatinib. # Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary CNS tumors, urothelial carcinoma, breast cancer, gastric cancer. # Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions). Sponsor: Taiho Oncology, Inc. Intervention: Futibatinib Start Date: 2014-07 Last Updated: 2022-01-10 Number of Patients: 386 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cholangiocarcinoma
NCTID: NCT03009058
Title: Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer Study Summary: During this open label study patients will receive IMM-101 in conjunction with a recognised standard of care for metastatic or unresectable cancer for the patient’s specific tumour type. The primary objective of the study is to provide safety data for IMM-101 in combination with a number of selected standard of care regimens. Sponsor: Immodulon Therapeutics Ltd Intervention: IMM-101 Start Date: 2017-05-24 Last Updated: 2018-08-09 Number of Patients: 2 Recruitment Status: TERMINATED Condition: Metastatic Cancer
NCTID: NCT04628494
Title: A Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in R/R DLBCL Study Summary: The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator’s choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT Sponsor: Genmab Intervention: Epcoritamab Start Date: 2021-01-13 Last Updated: 2023-08-07 Number of Patients: 552 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT03793478
Title: Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood Study Summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it has come back after remission or is not responding to treatment. Sponsor: Daiichi Sankyo, Inc. Intervention: Quizartinib Start Date: 2018-08-15 Last Updated: 2023-10-13 Number of Patients: 65 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT01303094
Title: Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma Study Summary: This randomization discontinuation trial will allow for concomitant evaluation of the following: * Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle * Side effects and benefits of a drug holiday Sponsor: Centre Oscar Lambret Intervention: Trabectedin Start Date: 2011-02 Last Updated: 2019-05-31 Number of Patients: 53 Recruitment Status: COMPLETED Condition: Soft Tissue Sarcoma
NCTID: NCT03306394
Title: A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic). Study Summary: The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC). Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor’s prescription or can be accessed from another source or Sponsor decision. Sponsor: Institut de Recherches Internationales Servier Intervention: Trifluridine/Tipiracil hydrochloride (S95005) Start Date: 2016-10-18 Last Updated: 2021-11-17 Number of Patients: 907 Recruitment Status: COMPLETED Condition: Metastatic Colorectal Cancer
NCTID: NCT04774718
Title: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors Study Summary: This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available. Sponsor: Hoffmann-La Roche Intervention: Alectinib Start Date: 2021-09-14 Last Updated: 2023-11-07 Number of Patients: 42 Recruitment Status: RECRUITING Condition: ALK Fusion-positive Solid or CNS Tumors
NCTID: NCT03786094
Title: Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Study Summary: This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer. Sponsor: Spexis AG Intervention: Eribulin Start Date: 2019-05-30 Last Updated: 2023-11-01 Number of Patients: 432 Recruitment Status: TERMINATED Condition: Metastatic Breast Cancer
NCTID: NCT01569295
Title: Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela ) Study Summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL) Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2012-06-15 Last Updated: 2020-03-10 Number of Patients: 416 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT05183984
Title: Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer Study Summary: Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab. Sponsor: ARCAGY/ GINECO GROUP Intervention: Chemotherapy Start Date: 2022-02-01 Last Updated: 2022-12-06 Number of Patients: 390 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT05587296
Title: A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer Study Summary: Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy. VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer. It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy. The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary. The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment. To see how safe elinzanetant is compared to placebo. The study will collect information about the number of participants who have medical problems after taking treatment. The study participants will be randomly (by chance) assigned to 2 treatment groups, A and B. The participants from treatment group A will take elinzanetant. The participants from treatment group B will start with placebo and then switch to elinzanetant. All participants will continue taking the anti-cancer therapy they have been using when entering the study. Dependent on the treatment group, the participants will either take elinzanetant or placebo as capsules by mouth once a day. After 12 weeks, the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks. Each participant will be in the study for approximately 62 weeks. The treatment duration in the study will be 52 weeks. There will be up to 12 visits to the study site and 6 phone calls in between. Participants who completed the 52 weeks treatment phase, will be offered to continue treatment for another 2 years. Visit frequency: every 24 weeks until week 152. During the study, the participants will: * record information about their hot flashes * answer questions about their quality of life and other symptoms. The doctors and their study team will: * check the participants health and vital signs * take blood and urine samples * examine heart health using electrocardiogram (ECG) * examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs * make images of the breast using x-ray (mammogram), a type of radiation that passes through the body to make images of the inside and/or by using ultrasound (if applicable) * check the health of the participant’s cervix (neck of the womb) by taking a small sample of cells (smear test) for an analysis called cervical cytology (if applicable) * take an endometrial biopsy, a small piece of tissue from the lining of the womb (called the endometrium) for analysis. * ask the participants questions about what medicines they are taking and if they are having adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. About 4 weeks after the participants take their last treatment, the study doctors and their team will check the participants’ health. Sponsor: Bayer Intervention: Elinzanetant (BAY3427080) Start Date: 2022-10-14 Last Updated: 2023-11-13 Number of Patients: 405 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
NCTID: NCT01526928
Title: Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients Study Summary: Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation. Sponsor: Clovis Oncology, Inc. Intervention: Rociletinib Start Date: 2012-03-27 Last Updated: 2020-08-04 Number of Patients: 612 Recruitment Status: TERMINATED Condition: Locally Advanced or Metastatic Non Small Cell Lung 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: NCT02975934
Title: A Study of Rucaparib Versus Physician’s Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency Study Summary: The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician’s choice of abiraterone acetate, enzalutamide, or docetaxel. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2017-06-13 Last Updated: 2023-11-07 Number of Patients: 405 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Castration Resistant Prostate Cancer
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: NCT04050436
Title: Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer Study Summary: To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review. Sponsor: Replimune Inc. Intervention: Cemiplimab Start Date: 2019-10-08 Last Updated: 2023-02-03 Number of Patients: 231 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cutaneous Squamous Cell Carcinoma
NCTID: NCT05275478
Title: Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors Study Summary: This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG908, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 192 participants. Sponsor: Tango Therapeutics, Inc. Intervention: TNG908 Start Date: 2022-03-23 Last Updated: 2023-08-01 Number of Patients: 192 Recruitment Status: RECRUITING Condition: Locally Advanced Solid Tumor
NCTID: NCT00718523
Title: Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer Study Summary: This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma. Sponsor: Translational Research in Oncology Intervention: AMG 479 Start Date: 2009-01 Last Updated: 2016-01-12 Number of Patients: 170 Recruitment Status: TERMINATED Condition: Ovarian Neoplasms
NCTID: NCT01957436
Title: A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer Study Summary: This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer. Sponsor: UNICANCER Intervention: abiraterone acetate Start Date: 2013-11-13 Last Updated: 2023-11-08 Number of Patients: 1173 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Prostate Cancer
NCTID: NCT04797780
Title: Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome Study Summary: This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (HR-MDS), and who have not received treatment for this diagnosis. The primary goal of the study is to compare the complete remission rate between the two treatment arms. Sponsor: Syros Pharmaceuticals Intervention: Tamibarotene Start Date: 2021-02-08 Last Updated: 2023-11-15 Number of Patients: 550 Recruitment Status: RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT01796002
Title: Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma Study Summary: Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by a Response Adjudication Committee (RAC). Sponsor: The Lymphoma Academic Research Organisation Intervention: Romidepsin + CHOP Start Date: 2013-01 Last Updated: 2023-01-10 Number of Patients: 421 Recruitment Status: COMPLETED Condition: Peripheral T-cell Lymphoma
NCTID: NCT02511678
Title: Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases Study Summary: This study will evaluate the efficacy of cryoablation for palliation of painful metastases in participants with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain relief from current pain therapies (for example, radiation, analgesics). Sponsor: Boston Scientific Corporation Intervention: Cryoablation Start Date: 2016-02-15 Last Updated: 2021-07-19 Number of Patients: 73 Recruitment Status: COMPLETED Condition: Pain
NCTID: NCT05566795
Title: DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) Study Summary: This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of DAY101 monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy. Sponsor: Day One Biopharmaceuticals, Inc. Intervention: DAY101 Start Date: 2023-02-27 Last Updated: 2023-11-22 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Low-grade Glioma
NCTID: NCT00642395
Title: Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT) Study Summary: Intensification with autologous stem cell
