Trials (Saolta University Cancer Network Galway University Hospitals)

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NCTID: NCT01176487

Title: Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer. ICORG 06-34 
Study Summary: RATIONALE: 3-dimensional conformal radiation therapy may lessen side effects caused by palliative radiation therapy and improve the quality of life of patients with lung cancer.  PURPOSE: This clinical trial is studying how well 3-dimensional conformal radiation therapy works in reducing the side effects of palliative radiation in patients with lung cancer. 
Sponsor: Cancer Trials Ireland 
Intervention: questionnaire administration 
Start Date: 2010-06 
Last Updated: 2016-03-31 
Number of Patients: 40 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT02308085

Title: Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer 
Study Summary: The best available evidence suggests that pregnancy after breast cancer does not increase a woman’s risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Endocrine therapy interruption 
Start Date: 2014-12-04 
Last Updated: 2023-03-16 
Number of Patients: 518 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Early Breast Cancer 

NCTID: NCT01272037

Title: Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer 
Study Summary: This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Anastrozole 
Start Date: 2011-01-15 
Last Updated: 2023-11-14 
Number of Patients: 5018 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Ductal Carcinoma In Situ 

NCTID: NCT02106143

Title: RejuvenAir™ System Lobectomy Safety and Histology Study 
Study Summary: Cryotherapy has a long history of safe use in various medical procedures. RejuvenAir System radial spray cryotherapy is a novel procedure being developed as a treatment for conditions associated with abnormal bronchial function, such as chronic bronchitis. The development of appropriate reliable equipment, definition of therapeutic parameters, and an understanding of the tissue effects of treatment have been established through animal studies. This clinical study is being undertaken to assess the feasibility and safety of the application of a radial metered dose spray cryotherapy in the human airway and to evaluate the treatment depth in human airways. The study design is prospective, open label, single arm multi-center study that will consist of up to 15 subjects at up to 3 enrolling sites in Ireland, UK and The Netherlands RejuvenAir System treatment will be performed during preoperative bronchoscopy 0 to 60 days prior to prescheduled lung resection in Subjects requiring lobectomy or pneumonectomy for removal of peripheral tumors. Treatment will be limited to areas of the bronchi within the lobe that will be removed, distal to the anticipated margin of resection. Treatment should be at least 1 cm from the bronchial resection margins and away from the tumor bed. Treated airways will be inspected via bronchoscopy at the time of thoracotomy, and examined histologically following surgical resection. Subject participation will be from 1 to 60 days and enrollment is anticipated to take 4-5 months.Total study duration is expected to last approximately 10 months. 
Sponsor: CSA Medical, Inc. 
Intervention: RejuvenAir™ Radial Spray Cryotherapy 
Start Date: 2014-09 
Last Updated: 2017-05-11 
Number of Patients: 11 
Recruitment Status: COMPLETED 
Condition: Lung Neoplasms 

NCTID: NCT00968643

Title: Spinal Cord Compression. ICORG 05-03, V6 
Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression.  PURPOSE: This randomized phase III trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression. 
Sponsor: Cancer Trials Ireland 
Intervention: radiation therapy 
Start Date: 2006-01 
Last Updated: 2014-12-31 
Number of Patients: 126 
Recruitment Status: COMPLETED 
Condition: Spinal Cord Compression 

NCTID: NCT05673187

Title: Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status 
Study Summary: ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2). 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Adagrasib 
Start Date: 2023-06-12 
Last Updated: 2023-11-18 
Number of Patients: 68 
Recruitment Status: RECRUITING 
Condition: NSCLC Stage IV 

NCTID: NCT01566747

Title: Second-line Pazopanib Renal Cell Carcinoma (RCC) Study. CTRIAL-IE (ICORG) 10-01, V5 
Study Summary: This is a phase II open label, single arm study evaluating treatment with pazopanib post sunitinib treatment in 43 patients with metastatic renal cell carcinoma. Patients will receive 800mg pazopanib per day given continuously until disease progression. Patients must have received treatment with sunitinib and relapsed. Patient must have received prior treatment with sunitinib for at least 12 weeks. Prior treatment with either temsirolimus or everolimus in addition to sunitinib is allowed. The trial design uses a Simons two stage design with an interim analysis planned after the first 15 evaluable patients. If 8 or more of the first 15 evaluable patients remains disease free at 4 months, then a further 28 patients will be enrolled for a total of 43 metastatic renal cell cancer patients. It is estimated that there could be up to 10% of patients dropping out and so to achieve the required number of 43 evaluable patients the study will recruit up to 48 patients to ensure that 43 complete if stage 2 is required.  Patients will receive treatment until disease progression, unacceptable toxicity or withdrawal of patient consent. Response assessments will be carried out every 8 weeks until disease progression. Safety assessments will be carried out every 4 weeks (plus a visit for liver function tests after 2 weeks) for the first six months and then every eight weeks until disease progression. A further safety assessment will be carried out 4 weeks after treatment discontinuation. 
Sponsor: Cancer Trials Ireland 
Intervention: Pazopanib 
Start Date: 2011-03 
Last Updated: 2021-12-23 
Number of Patients: 43 
Recruitment Status: COMPLETED 
Condition: Renal Cell Carcinoma 

NCTID: NCT02804815

Title: Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours 
Study Summary: Add-Aspirin aims to assess whether regular aspirin use after standard curative therapy can prevent recurrence and improve survival in individuals with non-metastatic common tumours. The question will be assessed in four different tumour types (breast, colorectal, gastro-oesophageal and prostate) by means of parallel cohorts within an overarching trial protocol.  Eligible participants will be randomly assigned (double-blind) to either aspirin 100mg, aspirin 300mg or a matched placebo, to be taken daily for at least 5 years. Disease recurrence and survival will be assessed, along with adherence, toxicity, and other potential effects of aspirin (eg. cardiovascular).  There is a large body of evidence indicating that aspirin has anti-cancer effects. Meta-analyses of cardiovascular trials of aspirin have shown short-term effects on cancer mortality and a decrease in risk of metastases, suggesting a role for aspirin in the treatment as well as prevention of cancer. Additionally, large observational studies of individuals taking aspirin after cancer treatment have shown improved disease-specific and overall mortality for specific tumour types.  In the treatment setting, the risks of side effects associated with aspirin are expected to be outweighed by potential benefits. However, this has not yet been assessed in a randomised trial.  As a low cost, generic and widely available drug, which is generally safe, if aspirin is shown to be effective, it could have a huge impact on cancer outcomes globally. 
Sponsor: University College, London 
Intervention: Aspirin 100mg 
Start Date: 2015-10 
Last Updated: 2021-02-21 
Number of Patients: 11000 
Recruitment Status: RECRUITING 
Condition: Cancer 

NCTID: NCT01649856

Title: A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma 
Study Summary: This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months. 
Sponsor: Hoffmann-La Roche 
Intervention: CHOP 
Start Date: 2012-08-24 
Last Updated: 2017-10-11 
Number of Patients: 572 
Recruitment Status: COMPLETED 
Condition: Lymphoma, Large B-Cell, Diffuse 

NCTID: NCT00182715

Title: Combination Chemotherapy With or Without Cetuximab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy and cetuximab are more effective than combination chemotherapy alone in treating colorectal cancer.  PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone as first-line therapy in treating patients with metastatic colorectal cancer. 
Sponsor: Velindre NHS Trust 
Intervention: cetuximab 
Start Date: 2005-03 
Last Updated: 2013-09-17 
Number of Patients: 2421 
Recruitment Status: UNKNOWN 
Condition: Colorectal Cancer 

NCTID: NCT05429268

Title: Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) 
Study Summary: The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). 
Sponsor: Incyte Corporation 
Intervention: Tafasitamab 
Start Date: 2022-12-23 
Last Updated: 2023-11-24 
Number of Patients: 81 
Recruitment Status: RECRUITING 
Condition: Large B-Cell Lymphoma 

NCTID: NCT02755597

Title: A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy 
Study Summary: This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma. 
Sponsor: AbbVie 
Intervention: Venetoclax 
Start Date: 2016-07-11 
Last Updated: 2023-08-22 
Number of Patients: 291 
Recruitment Status: COMPLETED 
Condition: Relapsed/Refractory Multiple Myeloma 

NCTID: NCT03997643

Title: Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial 
Study Summary: The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options. 
Sponsor: Lawson Health Research Institute 
Intervention: Radiotherapy to all dissected areas 
Start Date: 2019-09-06 
Last Updated: 2023-08-03 
Number of Patients: 90 
Recruitment Status: RECRUITING 
Condition: Head and Neck Cancer 

NCTID: NCT05710666

Title: Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study) 
Study Summary: This study is a Phase 2 open label, single arm, adaptive multi-centre trial. Patients with early stage HER2-positive breast cancer will receive neoadjuvant treatment of trastuzumab deruxtecan (T-DXd) 5.4mg/kg intravenously every three weeks for up to six cycles. 
Sponsor: Cancer Trials Ireland 
Intervention: trastuzumab deruxtecan (T-DXd) (IV) 
Start Date: 2023-11 
Last Updated: 2023-10-26 
Number of Patients: 80 
Recruitment Status: NOT_YET_RECRUITING 
Condition: HER2-positive Breast Cancer 

NCTID: NCT01746225

Title: Schedules of Nab-Paclitaxel in Metastatic Breast Cancer 
Study Summary: Longer first line chemotherapy duration has recently been associated with a modest, but significant improvement in overall survival and a clinically meaningful and statistically significant improvement in progression-free survival, in metastatic breast cancer patients. Prolonging chemotherapy until disease progression, however, must be weighed against the detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the tolerability of prolonged chemotherapy administration strategy by studying alternative treatment schedules, while preserving and possibly improving treatment efficacy in this disease setting.  The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®), represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an attempt to reduce the toxicity associated with standard taxane administration (caused by the use of chemical solvents) while increasing antitumor efficacy.  The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged chemotherapy administration strategy. Each of three arms will be compared to a historical reference of seven-month median progression-free survival (PFS) based on the most recent trial with docetaxel as control arm to determine whether any of the three arms are worthy of further investigation. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: nab-Paclitaxel 
Start Date: 2013-04 
Last Updated: 2023-06-01 
Number of Patients: 258 
Recruitment Status: COMPLETED 
Condition: Metastatic Breastcancer 

NCTID: NCT01767155

Title: Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer 
Study Summary: Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin. 
Sponsor: AEterna Zentaris 
Intervention: AEZS-108 / zoptarelin doxorubicin 
Start Date: 2013-04 
Last Updated: 2018-07-31 
Number of Patients: 511 
Recruitment Status: COMPLETED 
Condition: Endometrial Cancer 

NCTID: NCT01169337

Title: Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma 
Study Summary: This randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Clinical Observation 
Start Date: 2011-01-24 
Last Updated: 2023-11-21 
Number of Patients: 226 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Light Chain Deposition Disease 

NCTID: NCT02225704

Title: Radium-223 in Combination With Enzalutamide 
Study Summary: This study aims to determine the safety and tolerability of Radium-223 when administered in combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer. 
Sponsor: Cancer Trials Ireland 
Intervention: Radium-223 and enzalutamide 
Start Date: 2015-06-03 
Last Updated: 2023-04-06 
Number of Patients: 45 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT03069352

Title: A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy 
Study Summary: The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML). 
Sponsor: AbbVie 
Intervention: Placebo 
Start Date: 2017-05-23 
Last Updated: 2023-07-03 
Number of Patients: 211 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Acute Myeloid Leukemia (AML) 

NCTID: NCT00255606

Title: Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer.  PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer. 
Sponsor: Tampere University 
Intervention: docetaxel 
Start Date: 2005-08 
Last Updated: 2013-06-26 
Number of Patients: 360 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT01726452

Title: NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study (Neo-AEGIS) 
Study Summary: This is a multicentre phase III open-labelled, randomised controlled trial. Eligible patients will be randomised in a 1:1 fashion between neoadjuvant and adjuvant chemotherapy (Investigator’s choice modified MAGIC (ECF/ECX or EOF/EOX) or FLOT regimen) and surgery or Arm B (CROSS protocol: chemotherapy with radiation therapy and surgery as per multimodal protocol).  Primary Objective:  To evaluate one, two and three year survival of patients treated with resection plus neoadjuvant and adjuvant chemotherapy versus resection plus neoadjuvant chemo radiotherapy.  Secondary Objective(s):  To evaluate the effect of both neoadjuvant regimens on clinical and pathological response rate (in particular relief of dysphagia, improvement in health related quality of life (HRQL), endoscopic regression, and CT-PET evidence of tumour response), tumour regression grade, node-positivity, post-operative pathology, disease-free survival, time to treatment failure, toxicity, post-operative complications and Health Related Quality of Life (HRQL).  Exploratory Objective(s):  Translational Research: The collection of blood and tissue samples for storage in the bio bank for future research. 
Sponsor: Cancer Trials Ireland 
Intervention: Epirubicin 
Start Date: 2013-01-24 
Last Updated: 2022-09-30 
Number of Patients: 377 
Recruitment Status: COMPLETED 
Condition: Adenocarcinoma of the Oesophagus 

NCTID: NCT04680052

Title: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. 
Study Summary: This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL. 
Sponsor: Incyte Corporation 
Intervention: tafasitamab 
Start Date: 2021-04-15 
Last Updated: 2023-08-18 
Number of Patients: 654 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Follicular Lymphoma 

NCTID: NCT04667663

Title: CPD-DARA in Patients With Relapsed/Refractory Multiple Myeloma. 
Study Summary: This study is a Phase Ib, open label, single arm, adaptive multi-centre clinical study. The target population for this study are patients with relapsed/refractory multiple myeloma (MM). Patients will have a confirmed diagnosis of MM, with measurable disease as per IMWG criteria, in the second relapse and beyond (third line of therapy and beyond). Patients will need to have exposure to lenalidomide and a proteasome inhibitor. Patients will be treated with Cyclophosphamide-Pomalidomide-Dexamethasone (CPD) in combination with daratumumab (DARA) to determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D) of the combination.  Pomalidomide will be administered orally at three dose levels 4, 3 and 2mg on days 1-21 of each 28-day cycle. Treatment will be repeated on day 1 of a 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, physician’s decision, or sponsor’s decision to terminate the study, whichever occurs first. 
Sponsor: Cancer Trials Ireland 
Intervention: Daratumumab 
Start Date: 2021-12-08 
Last Updated: 2023-11-27 
Number of Patients: 20 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT03969004

Title: Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma 
Study Summary: The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT).  The secondary objectives of the study are:  * To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients’ freedom from locoregional recurrence (FFLRR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients’ freedom from distant recurrence (FFDR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT * To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT * To assess cemiplimab pharmacokinetics and immunogenicity in human serum 
Sponsor: Regeneron Pharmaceuticals 
Intervention: Cemiplimab 
Start Date: 2019-06-04 
Last Updated: 2023-11-24 
Number of Patients: 412 
Recruitment Status: RECRUITING 
Condition: Cutaneous Squamous Cell Carcinoma 

NCTID: NCT05757427

Title: Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection 
Study Summary: The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.  Microwave imaging is an emerging imaging modality for the early detection of breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at the microwave frequency spectrum.  This study is a pilot Clinical Evaluation of a microwave imaging system (Wavelia #2) for Breast Cancer Detection. The clinical data that will be collected in the context of this study is intended for the assessment of the imaging diagnostic capability and the safety of the investigational device. 
Sponsor: MVG Industries SAS 
Intervention: Wavelia #2 
Start Date: 2023-03-09 
Last Updated: 2023-03-14 
Number of Patients: 103 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT02306291

Title: Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML 
Study Summary: This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease. 
Sponsor: GlycoMimetics Incorporated 
Intervention: GMI-1271 
Start Date: 2015-03 
Last Updated: 2019-05-17 
Number of Patients: 91 
Recruitment Status: COMPLETED 
Condition: Leukemia, Myeloid, Acute 

NCTID: NCT01147939

Title: Study of Elacytarabine Versus Investigator’s Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML) 
Study Summary: The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator’s choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML). 
Sponsor: Clavis Pharma 
Intervention: Elacytarabine 
Start Date: 2010-06 
Last Updated: 2013-09-27 
Number of Patients: 381 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia (AML) 

NCTID: NCT01774279

Title: interNational Anaplastic Thyroid Cancer Tissue Bank and Database (iNATT) 

Study Summary: Anaplastic thyroid cancer has historically proven very difficult to research due to a combination of its rarity and the associated short survival period for those affected. In 2009, 2340 patients in the UK were diagnosed with thyroid cancer with 70-90 expected to be the anaplastic subtype 1,2. For these patients average life expectancy is in the range of 2-6 months with only a very small number surviving for more than one year. It is a highly aggressive form of cancer that is refractory to current treatment options. By collecting tissue and blood samples along with clinical data across the UK we will be able to accumulate numerically significant numbers of samples and data points which will facilitate research opportunities. Researchers will be encouraged to apply for access to the collected samples in order to try and establish the causal mechanisms for disease development, potential therapeutic targets and to relate clinical course and outcome with specific molecular defects. Due to the rarity it is not feasible for a single cancer centre or cancer network to accumulate sufficient samples for research in a meaningful timeframe hence the need for national collaboration in order to try and offer patients with this disease hope in the future. All UK patients with anaplastic thyroid cancer would be potentially eligible. The project is expected to run for at least 15 years and all thyroid cancer clinicians will be encouraged to participate. Patients will be asked to donate surplus thyroid cancer tissue following routine biopsy procedures along with an optional blood sample.

2. Objectives

Primary Objectives The primary objective of this project is to establish a national anaplastic thyroid cancer tissue collection to help facilitate both basic and translational research opportunities. There is no direct research question that the project itself addresses at this stage. The research proposals that subsequently arise as a result of this project will be generated by accredited research parties from the UK and potentially internationally. These research proposals will be submitted to the interNational Anaplastic Thyroid Cancer Tissue Bank and Database Project (iNATT) Steering Committee for assessment. As the volume of material collected per patient is expected to be of small volume, by virtue of the specimen comprising core biopsy or fine needle aspirate material, research proposals will need to be prioritised according to the potential benefits the proposed research offers. Priority will be given to projects that may lead to the identification of potential therapeutic targets. Each research proposal will require their own ethical approval and research and development assessments before commencing. The steering committee will be multidisciplinary and will include nationally respected researchers and thyroid cancer clinicians. Scientific Justification The long term objective is to try and address the current lack of understanding about the aetiology and progression of this disease and ultimately to develop new therapeutic interventions that may slow the rate of disease progression, improve quality of life and prolong what is currently a very short survival. Due to the short prognosis following diagnosis it is notoriously difficult to run interventional therapeutic clinical trials in this patient population. Patients usually present with locally advanced and metastatic disease and as a consequence are often of poor performance status making clinical trial participation very problematic. If potential therapeutic targets could be identified in vivo it would potentially open up new therapeutic avenues whilst sparing some patients with the ‘wrong’ molecular profile futile treatment. This is a unique project within the setting of anaplastic thyroid cancer research.

Sponsor: Velindre NHS Trust 
Intervention: Tissue, blood and clinical data collection 
Start Date: 2013-06 
Last Updated: 2021-01-05 
Number of Patients: 350 
Recruitment Status: RECRUITING 
Condition: Anaplastic Thyroid Cancer 

NCTID: NCT01796171

Title: A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma 
Study Summary: This study is a phase I/II open-label study in patients with relapsed indolent NHL (Part A) or relapsed/refractory FL (Part B). Part A of the study assessed the safety and preliminary efficacy. This seamless design study now has four parts: 1) Part A, Ph I - dose escalation, 2) Part A, Ph II - dose expansion, 3) Part B, Ph II randomized - refinement of dose, and 4) Part B and C, Phase II, single-arm. As of August 7, 2020, patients are enrolling in the fourth part of the study. 
Sponsor: Nordic Nanovector 
Intervention: Betalutin 
Start Date: 2012-12 
Last Updated: 2022-09-14 
Number of Patients: 191 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-Hodgkin Lymphoma 

NCTID: NCT01872975

Title: Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery 
Study Summary: This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer 
Sponsor: NSABP Foundation Inc 
Intervention: regional nodal XRT 
Start Date: 2013-08 
Last Updated: 2023-08-15 
Number of Patients: 1636 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Stage IB Breast Cancer 

NCTID: NCT02446405

Title: Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer 
Study Summary: The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer. 
Sponsor: University of Sydney 
Intervention: Enzalutamide 
Start Date: 2014-03 
Last Updated: 2022-11-30 
Number of Patients: 1125 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostatic Neoplasms 

NCTID: NCT00324805

Title: Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery 
Study Summary: This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Bevacizumab 
Start Date: 2007-06-01 
Last Updated: 2023-11-21 
Number of Patients: 1501 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Stage IB Lung Non-Small Cell Carcinoma AJCC v7 

NCTID: NCT01945775

Title: A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) 
Study Summary: The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician’s choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations. 
Sponsor: Pfizer 
Intervention: talazoparib 
Start Date: 2013-10-14 
Last Updated: 2022-01-20 
Number of Patients: 431 
Recruitment Status: COMPLETED 
Condition: Breast Neoplasms 

NCTID: NCT05514054

Title: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer 
Study Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. 
Sponsor: Eli Lilly and Company 
Intervention: Imlunestrant 
Start Date: 2022-10-04 
Last Updated: 2023-10-24 
Number of Patients: 6000 
Recruitment Status: RECRUITING 
Condition: Breast Neoplasms 

NCTID: NCT01307397

Title: A Study of Vemurafenib in Participants With Metastatic Melanoma 
Study Summary: This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer <math display="block">AJCC</math>) metastatic melanoma. 
Sponsor: Hoffmann-La Roche 
Intervention: Vemurafenib 
Start Date: 2011-03-01 
Last Updated: 2017-12-18 
Number of Patients: 3219 
Recruitment Status: COMPLETED 
Condition: Malignant Melanoma 

NCTID: NCT02811861

Title: Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma 
Study Summary: The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review <math display="block">IIR</math> using Response Evaluation Criteria in Solid Tumors <math display="block">RECIST 1.1</math>) as first-line treatment in participants with advanced renal cell carcinoma (RCC). 
Sponsor: Eisai Inc. 
Intervention: Lenvatinib 
Start Date: 2016-10-13 
Last Updated: 2023-07-10 
Number of Patients: 1069 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Renal Cell Carcinoma 

NCTID: NCT02811822

Title: A Study to Determine the Efficacy, Safety and Pharmacokinetics of GMI-1271 as Adjunct to Standard of Care for the Treatment of Multiple Myeloma 
Study Summary: This study will evaluate GMI-1271, a specific E-selectin antagonist, in multiple myeloma as adjunct to standard of care chemotherapy used to treat this disease. 
Sponsor: GlycoMimetics Incorporated 
Intervention: GMI-1271 
Start Date: 2016-06 
Last Updated: 2019-07-10 
Number of Patients: 10 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT01712789

Title: Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma 
Study Summary: The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.  The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years.  In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses.  The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers. 
Sponsor: Celgene 
Intervention: Pomalidomide 
Start Date: 2012-11-06 
Last Updated: 2022-01-10 
Number of Patients: 682 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT00974168

Title: Spinal Cord Compression Re-Treat Study 
Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may be effective in treating malignant spinal cord compression in patients who have received previous radiation therapy to the spine.  PURPOSE: This phase II trial is studying radiation therapy in treating patients with malignant spinal cord compression. 
Sponsor: Cancer Trials Ireland 
Intervention: Cumulative BED ≤ 100 
Start Date: 2007-10 
Last Updated: 2019-07-29 
Number of Patients: 22 
Recruitment Status: COMPLETED 
Condition: Pain 

NCTID: NCT00424047

Title: A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma 
Study Summary: To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma." 
Sponsor: Celgene 
Intervention: CC-5013 plus dexamethasone 
Start Date: 2003-01-01 
Last Updated: 2017-10-19 
Number of Patients: 351 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT01251861

Title: Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer 
Study Summary: This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Akt Inhibitor MK2206 
Start Date: 2010-12-23 
Last Updated: 2023-08-01 
Number of Patients: 108 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Recurrent Prostate Carcinoma 

NCTID: NCT03970564

Title: Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer 
Study Summary: This is a study of routine neck ultrasound performed by respiratory physicians in patients with mediastinal lymphadenopathy and suspected lung cancer 
Sponsor: University College Hospital Galway 
Intervention: Neck ultrasound guide lymph node sampling 
Start Date: 2016-10-21 
Last Updated: 2019-05-31 
Number of Patients: 30 
Recruitment Status: COMPLETED 
Condition: Lung Cancer Metastatic 

NCTID: NCT04136353

Title: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate 
Study Summary: The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence. 
Sponsor: University of Sydney 
Intervention: Darolutamide 
Start Date: 2020-03-31 
Last Updated: 2023-07-28 
Number of Patients: 1100 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostate Cancer 

NCTID: NCT02506153

Title: High-Dose Recombinant Interferon Alfa-2B, Ipilimumab, or Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery 
Study Summary: This randomized phase III trial studies how well high-dose recombinant interferon alfa-2B or ipilimumab works compared with pembrolizumab in treating patients with stage III-IV melanoma that has been removed by surgery but is likely to come back or spread. High-dose recombinant interferon alfa-2B may help shrink or slow the growth of melanoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether high-dose recombinant interferon alfa-2B or ipilimumab is more effective than pembrolizumab in treating patients with melanoma. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Ipilimumab 
Start Date: 2015-10-15 
Last Updated: 2023-09-13 
Number of Patients: 1378 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Cutaneous Melanoma 

NCTID: NCT02160353

Title: Neo-adjuvant Abiraterone Prostate Study 
Study Summary: The role of this study is to focus on the potential role of abiraterone acetate in treatment-naive patients newly diagnosed with high-risk localised prostate cancer requiring combined hormonal therapy and radiotherapy. 
Sponsor: Cancer Trials Ireland 
Intervention: Abiraterone acetate, Prednisolone 
Start Date: 2015-07-09 
Last Updated: 2023-04-06 
Number of Patients: 45 
Recruitment Status: COMPLETED 
Condition: High Risk Localised Prostate Carcinoma 

NCTID: NCT06115629

Title: Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial 

Study Summary: Cancer of the food pipe (oesophagus) and stomach are increasingly common. Currently, most patients with cancer of the oesophagus and stomach are treated with surgery with or without additional chemotherapy or radiotherapy. In recent years there have been improvements in survival from these two cancers, due to better therapies, less invasive surgery and earlier detection. Despite these improvements, in around half of patients treated with surgery, the cancer will return, usually within the first three years. At present there is very little evidence as to how patients who have been treated for cancer of the oesophagus or stomach should be followed up after surgery and whether different methods of follow-up could improve survival. Currently, national and international guidelines do not provide consistency in their recommendations for follow-up after surgery. The SARONG-II study will investigate if regular radiological scans can lead to earlier detection of a cancer returning, at a stage when it may be more readily treatable. This means that participants who agree to take part will be allocated by chance to either more intensive imaging surveillance (including regular radiological scans and a camera test (endoscopy)) or clinical follow-up. The study aims to recruit at least 952 participants in Europe over a 32-month period. Patients undergoing surgery for oesophageal or stomach cancer will be invited to participate in the study at around 4 to 8 weeks after their surgery.

1. The imaging surveillance group will receive a review in clinic or by telephone with a member of the surgical team, and a radiological scan at 6, 12, 18, 24, 30 and 36 months after randomisation. They will also receive endoscopy at 12 months after randomisation (ii) The clinical surveillance group will receive a review in clinic or by telephone at 6, 12, 18, 24, 30 and 36 months. After this they will be either discharged to their local doctor or receive a review in clinic with a member of the surgical team every year according to local practice

The main aim of this study will be to determine whether earlier detection of cancer through more intensive follow-up results in improved survival and better quality of life for patients with oesophagus or stomach cancer. The investigators anticipate the results of the study may have significant practice-changing impact for patients undergoing follow-up after surgery for oesophagus and stomach cancer.

Sponsor: University of Dublin, Trinity College 
Intervention: Surveillance protocol 
Start Date: 2023-11 
Last Updated: 2023-11-03 
Number of Patients: 952 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Esophageal Cancer 

NCTID: NCT02610777

Title: An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML) 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML. 
Sponsor: Millennium Pharmaceuticals, Inc. 
Intervention: Azacitidine 
Start Date: 2016-04-14 
Last Updated: 2022-09-19 
Number of Patients: 120 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndromes 

NCTID: NCT04961996

Title: A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) 
Study Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.  In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. 
Sponsor: Hoffmann-La Roche 
Intervention: Giredestrant 
Start Date: 2021-08-27 
Last Updated: 2023-11-18 
Number of Patients: 4200 
Recruitment Status: RECRUITING 
Condition: Early Breast Cancer 

NCTID: NCT05123131

Title: Isa-RVD Study in Patients With Newly Diagnosed Multiple Myeloma 
Study Summary: This study aims to evaluate the stringent Complete Response (sCR) rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved sCR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment. 
Sponsor: Cancer Trials Ireland 
Intervention: Isatuximab 
Start Date: 2022-04-01 
Last Updated: 2023-06-01 
Number of Patients: 43 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT00069121

Title: A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer 
Study Summary: This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals. 
Sponsor: Hoffmann-La Roche 
Intervention: Capecitabine 
Start Date: 2003-04-18 
Last Updated: 2020-03-06 
Number of Patients: 1886 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT03374488

Title: Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma 
Study Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease. 
Sponsor: Incyte Corporation 
Intervention: Pembrolizumab 
Start Date: 2017-12-22 
Last Updated: 2021-11-30 
Number of Patients: 84 
Recruitment Status: COMPLETED 
Condition: UC (Urothelial Cancer) 

NCTID: NCT03226964

Title: Assessment of High Flow Nasal Cannula Oxygenation in EBUS Bronchoscopy 
Study Summary: This study is a prospective randomised trial where a computer will randomly allocate  patients to one of two possible methods of delivering oxygen during the procedure of  bronchoscopy. This trial compares high flow nasal cannula (HFNC) with nasal prongs in  delivering oxygen to patients undergoing endo-bronchial ultrasound guided trans-  bronchial nodal aspiration (EBUS-TBNA) a specialised form of bronchoscopy procedure.  HFNC uses humidified higher gas flow rates than conventional low flow systems such as  nasal prongs which are limited by the respiratory rate and effort. 
Sponsor: University College Hospital Galway 
Intervention: high flow nasal oxygen 
Start Date: 2016-10-01 
Last Updated: 2018-05-02 
Number of Patients: 40 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT01772472

Title: A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) 
Study Summary: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated. 
Sponsor: Hoffmann-La Roche 
Intervention: trastuzumab 
Start Date: 2013-04-03 
Last Updated: 2023-11-13 
Number of Patients: 1487 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT05352672

Title: Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma 
Study Summary: The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS)  The secondary objectives of the study are:  * To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) * To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab * To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component * To assess immunogenicity of fianlimab and cemiplimab * To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults * To characterize safety and tolerability of treatment in patients 12 to <18 years of age * To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age * To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab * To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years 
Sponsor: Regeneron Pharmaceuticals 
Intervention: Fianlimab 
Start Date: 2022-07-14 
Last Updated: 2023-11-24 
Number of Patients: 1590 
Recruitment Status: RECRUITING 
Condition: Melanoma 

NCTID: NCT02955810

Title: Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) With Daratumumab (DARA) 
Study Summary: This study is a Phase Ib open label, single arm, adaptive multicentre trial. Patients with newly diagnosed Multiple Myeloma (MM) will be treated with Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) in combination with Daratumumab (DARA).  The safety profile of daratumumab to date, which does not appear to overlap with those known for approved agents, combined with its distinct MoA, suggest that the therapeutic profile of daratumumab combined with various backbone regimens may improve the treatment effect of these regimens. Additionally, daratumumab as a single agent may prolong the progression free interval for these patients. Based on the potential for cyclophosphamide to enhance ADCP, there is a strong rationale to combine DARA with a cyclophosphamide, bortezomib containing regimen. This will be the first clinical trial to explore the feasibility of combining daratumumab with a cyclophosphamide containing backbone induction regimen and if successful will provide the rationale for larger studies exploring the efficacy of this combination in greater detail. 
Sponsor: National University of Ireland, Galway, Ireland 
Intervention: Daratumumab 
Start Date: 2016-11 
Last Updated: 2018-03-29 
Number of Patients: 18 
Recruitment Status: UNKNOWN 
Condition: Multiple Myeloma 

NCTID: NCT03869762

Title: Denosumab in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases. 
Study Summary: Open-label phase II multi-centre single arm study of Denosumab in combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer. 
Sponsor: Cancer Trials Ireland 
Intervention: Xgeva 
Start Date: 2019-01-09 
Last Updated: 2023-04-13 
Number of Patients: 7 
Recruitment Status: TERMINATED 
Condition: Castration-resistant Prostate Cancer 

NCTID: NCT01910610

Title: Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer 
Study Summary: STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer. 
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group 
Intervention: FOLFIRI-cetuximab 
Start Date: 2013-10-30 
Last Updated: 2021-06-16 
Number of Patients: 474 
Recruitment Status: UNKNOWN 
Condition: Colorectal Cancer Metastatic 

NCTID: NCT02950051

Title: Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation 
Study Summary: The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab, Obinutuzumab), which may induce extremely long lasting remissions. 
Sponsor: German CLL Study Group 
Intervention: Fludarabine 
Start Date: 2016-12-13 
Last Updated: 2023-07-06 
Number of Patients: 926 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Chronic Lymphocytic Leukemia 

NCTID: NCT05896566

Title: A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer 
Study Summary: PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus anastrozole plus triptorelin (C). 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Giredestrant 
Start Date: 2023-12-01 
Last Updated: 2023-10-18 
Number of Patients: 220 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT01485926

Title: A Phase II Neo-adjuvant Study Assessing TCH (Docetaxel, Carboplatin and Trastuzumab) and TCHL (Docetaxel, Carboplatin, Trastuzumab and Lapatinib) in HER-2 Positive Breast Cancer Patients. 
Study Summary: The primary objective:  -To assess the efficacy of TCH and TCHL in neo-adjuvant treatment of HER-2 positive breast cancer, using pathological complete response (pCR) as the primary endpoint (Phase II).  Secondary objectives:  * To assess the clinical response rate and overall response rate for docetaxel and carboplatin with trastuzumab alone or trastuzumab combined with lapatinib in HER-2 positive breast cancer. * To assess the relationship between drug exposure and adverse events. * To examine potential molecular and pharmacological markers of response to trastuzumab and lapatinib * To assess Disease-free Survival (DFS) and Overall Survival (OS) * To determine if prophylactic Loperamide significantly reduces the number of diarrhoea -related adverse events. 
Sponsor: Cancer Trials Ireland 
Intervention: Docetaxel, Carboplatin and Trastuzumab 
Start Date: 2010-10 
Last Updated: 2018-08-06 
Number of Patients: 120 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT02836392

Title: CRQ Survey Study: Clinical Research Questionnaire of Oncology Patients - A Nationwide Survey 
Study Summary: This is a translational, multicentre questionnaire study. The study design follows that of a cross sectional, quantitative research approach. Data collection will involve self-administered, paper-based questionnaires. The method of data collection allows for a large sample size without major expense. The questionnaires are comprised of several questions examining areas such as demographic details, cancer diagnosis, understanding of the term ‘clinical trials’, attitudes to personal participation in cancer clinical research and the experience of patients who previously participated in a cancer clinical trial. The study will be opened in all interested hospitals in Ireland following initiation of the study at each site. Questionnaire completion will be seen as implied informed consent and no formal consent will need to be signed by the patient. The paper-based questionnaire responses will be electronically and anonymously recorded in a computer database to facilitate analysis. 
Sponsor: Cancer Trials Ireland 
Intervention: Questionnaire 
Start Date: 2016-05 
Last Updated: 2017-08-10 
Number of Patients: 1000 
Recruitment Status: COMPLETED 
Condition: Cancer 

NCTID: NCT01358877

Title: A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer 
Study Summary: This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG). 
Sponsor: Hoffmann-La Roche 
Intervention: 5-Fluorouracil 
Start Date: 2011-11-08 
Last Updated: 2023-10-04 
Number of Patients: 4804 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT00513877

Title: Bortezomib in Treating Patients With Malignant Pleural Mesothelioma 
Study Summary: RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.  PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma. 
Sponsor: Cancer Trials Ireland 
Intervention: bortezomib 
Start Date: 2006-05 
Last Updated: 2014-12-31 
Number of Patients: 33 
Recruitment Status: COMPLETED 
Condition: Malignant Mesothelioma 

NCTID: NCT01275677

Title: Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer 
Study Summary: This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Cyclophosphamide 
Start Date: 2011-01-06 
Last Updated: 2023-11-21 
Number of Patients: 3270 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: HER2 

eu Positive NCTID: NCT00004218

Title: Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for chronic lymphocytic leukemia.  PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with newly diagnosed chronic lymphocytic leukemia. 
Sponsor: Leukemia Research Fund 
Intervention: chlorambucil 
Start Date: 1999-10 
Last Updated: 2013-12-18 
Number of Patients: NA 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT04608318

Title: Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) 
Study Summary: The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL. 
Sponsor: German CLL Study Group 
Intervention: Ibrutinib 
Start Date: 2021-03-01 
Last Updated: 2023-02-23 
Number of Patients: 897 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Chronic Lymphoid Leukemia 

NCTID: NCT01495884

Title: The Myocet/Lapatinib Study. ICORG 10-03, V5 
Study Summary: This study is a Phase I/II open label, multi-centre trial. Patients with HER2+ve metastatic breast cancer, following disease progression during, or after, treatment with trastuzumab and taxanes, will be treated with Lapatinib (Tyverb™ 500-1250 mg orally daily - depending on the maximum tolerated dose (MTD) determined in the Phase I part of the study) plus Myocet™, 50-60 mg/m2 i.v q3 weeks).  Within the Phase I part, doses are assigned at registration according to the dose escalation scheme.  The dose for the Phase II part of the trial will be based on the MTD established in the Phase I part of the study.  Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity of study therapy. Safety assessments will be performed every 3 weeks for the first 24 weeks. Efficacy assessments (radiological examination) will be performed on all patients every 8 weeks (± 7 days) for the first 24 weeks. Cardiotoxicity assessments will be performed at weeks 6 and 12. From week 24, safety, efficacy and cardiotoxicity assessments will be performed every 12 weeks and at the end of treatment (disease progression, unacceptable toxicity or patient withdraws consent). 
Sponsor: Cancer Trials Ireland 
Intervention: non-pegylated liposomal doxorubicon (Myocet™) 
Start Date: 2011-03 
Last Updated: 2015-10-26 
Number of Patients: 11 
Recruitment Status: TERMINATED 
Condition: Her2 Positive Metastatic Breast 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: NCT00003734

Title: Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer 
Study Summary: RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin and flutamide may fight cancer by reducing the production of androgens. It is not yet known whether giving hormone therapy for 4 months is more effective than giving therapy for 8 months prior to radiation therapy for prostate cancer.  PURPOSE: Randomized phase III trial to study the effectiveness of combination hormone therapy for 4 or 8 months followed by radiation therapy in treating patients with prostate cancer. 
Sponsor: St. Luke’s Hospital, Ireland 
Intervention: flutamide 
Start Date: 1998-12 
Last Updated: 2016-07-21 
Number of Patients: 276 
Recruitment Status: UNKNOWN 
Condition: Prostate Cancer 

NCTID: NCT00310180

Title: Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) 
Study Summary: This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Anastrozole 
Start Date: 2006-04-07 
Last Updated: 2023-10-11 
Number of Patients: 10273 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Adenocarcinoma 

NCTID: NCT01510184

Title: Study of Zevalin Versus Observation in Participants at Least 60 Years Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in Positron Emission Tomography (PET)-Negative Complete Remission After Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like Therapy 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy. 
Sponsor: Spectrum Pharmaceuticals, Inc 
Intervention: Zevalin 
Start Date: 2012-04-19 
Last Updated: 2021-12-16 
Number of Patients: 79 
Recruitment Status: TERMINATED 
Condition: Diffuse Large B-cell Lymphoma 

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: NCT00689936

Title: Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma 
Study Summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide. 
Sponsor: Celgene 
Intervention: Lenalidomide and low-dose dexamethasone 
Start Date: 2008-08-21 
Last Updated: 2019-11-20 
Number of Patients: 1623 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT01562028

Title: BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC) 
Study Summary: Rationale:  Advanced non-small-cell lung cancer (NSCLC) patients harbouring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 14 months when treated with erlotinib. However, the presence of EGFR mutations can only imperfectly predict outcome. The investigators hypothesize that progression-free survival could be influenced both by the pretreatment EGFR T790M mutation and by components of DNA repair pathways.  The investigators propose a model of treatment whereby patients with EGFR mutations (single or with T790M) can attain a benefit with longer overall PFS when treated with erlotinib plus bevacizumab. When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Erlotinib 
Start Date: 2012-06 
Last Updated: 2022-08-24 
Number of Patients: 109 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT00470236

Title: Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast 
Study Summary: Hypotheses:  # The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast). # The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm. # A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization.  Overall Objectives:  # To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy. # To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity. 
Sponsor: Trans Tasman Radiation Oncology Group 
Intervention: Standard WB fractionation 
Start Date: 2007-06 
Last Updated: 2023-03-22 
Number of Patients: 1608 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Carcinoma, Ductal, Breast 

NCTID: NCT02219178

Title: Study of the Efficacy and Safety of RsqVD Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma 
Study Summary: This study aims to evaluate the overall response rate after 4 cycles and the best response to induction therapy with combination of lenalidomide, subcutaneous bortezomib, and dexamethasone (RsqVD) in patients with newly diagnosed multiple myeloma. 
Sponsor: Cancer Trials Ireland 
Intervention: lenalidomide 
Start Date: 2014-11 
Last Updated: 2020-07-17 
Number of Patients: 42 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT03322540

Title: Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05) 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1). 
Sponsor: Incyte Corporation 
Intervention: Pembrolizumab 
Start Date: 2017-12-15 
Last Updated: 2022-01-24 
Number of Patients: 154 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT02446444

Title: Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer 
Study Summary: The purpose of this study is to determine the effectiveness of enzalutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk of recurrence. 
Sponsor: University of Sydney 
Intervention: Enzalutamide 
Start Date: 2014-03 
Last Updated: 2022-12-19 
Number of Patients: 802 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostatic Neoplasms 

NCTID: NCT01822444

Title: ANGIOPREDICT. ICORG 12-16, V3 
Study Summary: Primary Objective:  The primary objective is to validate previously identified predictive/prognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC (a CRC) or metastatic CRC (mCRC).  Secondary Objective:  # To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and # To determine the progression free and overall survival of patients under first line FOLFOX + bvz in aCRC or mCRC. 
Sponsor: Cancer Trials Ireland 
Intervention: Biomarker analysis 
Start Date: 2012-11 
Last Updated: 2023-04-06 
Number of Patients: 76 
Recruitment Status: COMPLETED 
Condition: Advanced Colorectal Cancer 

NCTID: NCT00375674

Title: A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer 
Study Summary: To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery. 
Sponsor: Pfizer 
Intervention: Sunitinib malate 
Start Date: 2007-08-01 
Last Updated: 2018-09-21 
Number of Patients: 674 
Recruitment Status: COMPLETED 
Condition: Kidney Neoplasms 

NCTID: NCT00625898

Title: BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab 
Study Summary: The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer. 
Sponsor: NSABP Foundation Inc 
Intervention: Docetaxel 
Start Date: 2008-04 
Last Updated: 2020-09-10 
Number of Patients: 3509 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT03361865

Title: Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307) 
Study Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma. 
Sponsor: Incyte Corporation 
Intervention: Pembrolizumab 
Start Date: 2017-12-04 
Last Updated: 2021-12-16 
Number of Patients: 93 
Recruitment Status: COMPLETED 
Condition: UC (Urothelial Cancer) 

NCTID: NCT03616470

Title: Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia 
Study Summary: This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML 
Sponsor: GlycoMimetics Incorporated 
Intervention: Uproleselan 
Start Date: 2018-10-15 
Last Updated: 2023-07-25 
Number of Patients: 388 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT02129699

Title: Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy 
Study Summary: The purpose of this study is to investigate how well the standard treatment (platinum-based doublet chemotherapy) in combination with denosumab works compared with the standard treatment alone in patients with a type of lung cancer called “non small cell lung cancer” (NSCLC) that has spread to other parts of the body. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Denosumab 
Start Date: 2015-01-06 
Last Updated: 2020-08-11 
Number of Patients: 514 
Recruitment Status: COMPLETED 
Condition: Lung Cancer Non-small Cell Stage IV 

NCTID: NCT02690480

Title: Fulvestrant (F)+Placebo vs F+Palbociclib First Line for Postmenopausal Hormone Receptor+ Advanced Breast Cancer 
Study Summary: This is an international, multicentre, double-blind, controlled, randomized phase II study comparing the efficacy and safety of fulvestrant in combination with palbociclib versus fulvestrant plus placebo in postmenopausal women with HR-positive/HER2-negative metastatic breast cancer who have received ≥5 years of endocrine therapy in the adjuvant setting as treatment for early disease and remained disease free for > 12 months following its completion or have “de novo” metastatic disease. 
Sponsor: Spanish Breast Cancer Research Group 
Intervention: PD-0332991 (Palbociclib) 
Start Date: 2016-02-17 
Last Updated: 2020-02-05 
Number of Patients: 189 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Neoplasms 

NCTID: NCT01734928

Title: Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone. 
Sponsor: Celgene 
Intervention: Pomalidomide 
Start Date: 2013-01-07 
Last Updated: 2023-06-06 
Number of Patients: 559 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT01526369

Title: A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer 
Study Summary: The proposed phase III randomised trial will compare the efficacy of trastuzumab and paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2 positive metastatic breast cancer. The investigators will also examine potential predictive biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum samples. 
Sponsor: Cancer Trials Ireland 
Intervention: Trastuzumab 
Start Date: 2012-02-13 
Last Updated: 2023-04-06 
Number of Patients: 75 
Recruitment Status: COMPLETED 
Condition: Metastatic Breast Cancer 

NCTID: NCT00755976

Title: Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma 
Study Summary: RATIONALE: Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sulindac together with epirubicin may kill more tumor cells.  PURPOSE: This phase II trial is studying how well giving sulindac together with epirubicin works in treating patients with metastatic malignant melanoma. 
Sponsor: Cancer Trials Ireland 
Intervention: epirubicin hydrochloride 
Start Date: 2007-08 
Last Updated: 2014-12-31 
Number of Patients: 32 
Recruitment Status: COMPLETED 
Condition: Melanoma (Skin)

hasCancerType::C00-D48: All neoplasms hasCancerType::C00-C97: All cancer types hasCancerType::C00-C14: Mouth/throat cancers hasCancerType::C15-C26: Digestive system cancers hasCancerType::C30-C39: Lung/chest cancers hasCancerType::C40-C41: Bone cancers hasCancerType::C43-C44: Skin cancers/melanoma hasCancerType::C45-C49: Soft tissue cancer hasCancerType::C50: Breast cancer hasCancerType::C51-C58: Female genitalia cancers hasCancerType::C60-C63: Male genitalia cancer hasCancerType::C64-C68: Urinary system cancers hasCancerType::C69-C72: Eye and brain cancer hasCancerType::C73-C75: Thyroid and other gland cancers hasCancerType::C76-C80: Cancers of unknown or unspecified areas hasCancerType::C81-C96: Cancers of the blood and immune system hasCancerType::C97-C97: Cancers in multiple locations from the start hasCancerType::D00-D09: Early-stage cancers not yet spread hasCancerType::D10-D36: Benign tumour hasCancerType::D37-D48: Growths of uncertain nature hasCancerType::unknown isTrial