Editing Trials (Erasmus MC Kanker Instituut)

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'''NCTID''': NCT05208047 
 '''Title''': (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors 
 '''Study Summary''': This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. 
 '''Sponsor''': Cogent Biosciences, Inc. 
 '''Intervention''': CGT9486 plus sunitinib 
 '''Start Date''': 2022-04-14 
 '''Last Updated''': 2023-11-28 
 '''Number of Patients''': 426 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Advanced Gastrointestinal Stromal Tumors 
'''NCTID''': NCT04626479 
 '''Title''': Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) 
 '''Study Summary''': Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).  The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC).  This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2020-12-16 
 '''Last Updated''': 2023-11-24 
 '''Number of Patients''': 400 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Carcinoma, Renal Cell 
'''NCTID''': NCT03574571 
 '''Title''': A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer 
 '''Study Summary''': The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself. 
 '''Sponsor''': Memorial Sloan Kettering Cancer Center 
 '''Intervention''': Docetaxel 75 mg/m2 
 '''Start Date''': 2018-06-19 
 '''Last Updated''': 2023-11-13 
 '''Number of Patients''': 738 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Prostate Cancer 
'''NCTID''': NCT05050942 
 '''Title''': A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET 
 '''Study Summary''': The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029. 
 '''Sponsor''': Camurus AB 
 '''Intervention''': CAM2029 
 '''Start Date''': 2021-10-22 
 '''Last Updated''': 2023-10-06 
 '''Number of Patients''': 300 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Gastro-enteropancreatic Neuroendocrine Tumor 
'''NCTID''': NCT03604445 
 '''Title''': This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours) 
 '''Study Summary''': This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer.  One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment. 
 '''Sponsor''': Boehringer Ingelheim 
 '''Intervention''': BI 905677 
 '''Start Date''': 2018-08-08 
 '''Last Updated''': 2023-03-17 
 '''Number of Patients''': 37 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Neoplasms 
'''NCTID''': NCT01870609 
 '''Title''': Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma 
 '''Study Summary''': This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the study, each subject must have tumor Merlin status(high or low) established by immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1 ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be stratified by tumor Merlin status (high versus low). Progression will be assessed both locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression or other discontinuation criteria are met. Following documentation of nonfatal disease progression, all subjects will be followed for overall survival by telephone contact every 2 months until end of life or the close of the study. 
 '''Sponsor''': Verastem, Inc. 
 '''Intervention''': defactinib (VS-6063) 
 '''Start Date''': 2013-09 
 '''Last Updated''': 2017-01-30 
 '''Number of Patients''': 344 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Malignant Pleural Mesothelioma 
'''NCTID''': NCT00547651 
 '''Title''': AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy 
 '''Study Summary''': This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer. 
 '''Sponsor''': Celgene 
 '''Intervention''': Amrubicin 
 '''Start Date''': 2007-09-01 
 '''Last Updated''': 2019-11-06 
 '''Number of Patients''': 637 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Small Cell Lung Cancer 
'''NCTID''': NCT03448042 
 '''Title''': A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers 
 '''Study Summary''': This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers. 
 '''Sponsor''': Genentech, Inc. 
 '''Intervention''': Runimotamab 
 '''Start Date''': 2018-06-06 
 '''Last Updated''': 2023-11-02 
 '''Number of Patients''': 537 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Solid Tumors 
'''NCTID''': NCT01719380 
 '''Title''': Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer 
 '''Study Summary''': This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer 
 '''Sponsor''': Pfizer 
 '''Intervention''': LGX818 
 '''Start Date''': 2012-11-23 
 '''Last Updated''': 2021-06-23 
 '''Number of Patients''': 156 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Colorectal Cancer 
'''NCTID''': NCT04503278 
 '''Title''': A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX 
 '''Study Summary''': This is a Phase I/IIa, FIH, open-label, multicenter, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T/CLDN6 CAR-T(A) with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors.  The trial started with CLDN6 RNA-LPX, a liposomal formulation comprising an unmodified RNA. In order to optimize CAR-T cell persistence in patients, an alternative RNA-LPX, CLDN6 modRNA-LPX, will be tested once the RP2D dose for CLDN6 CAR-T(A) ± CLDN6 RNA-LPX is identified. 
 '''Sponsor''': BioNTech Cell &amp; Gene Therapies GmbH 
 '''Intervention''': CLDN6 CAR-T/CLDN6 CAR-T(A) 
 '''Start Date''': 2020-09-16 
 '''Last Updated''': 2023-11-27 
 '''Number of Patients''': 114 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Solid Tumor