Condition: Prostatic Neoplasms, Castration-Resistant · Sponsor: Merck Sharp & Dohme LLC
Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.
This description comes directly from the study's public registry record.
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| UCSD Moores Cancer Center ( Site 0039) | La Jolla, California, United States | Recruiting |
| UCLA Hematology/Oncology - Santa Monica ( Site 0044) | Los Angeles, California, United States | Recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051) | Miami, Florida, United States | Recruiting |
| University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049) | Baltimore, Maryland, United States | Active Not Recruiting |
| Rutgers Cancer Institute of New Jersey ( Site 0033) | New Brunswick, New Jersey, United States | Active Not Recruiting |
| University Hospitals Cleveland Medical Center ( Site 0043) | Cleveland, Ohio, United States | Recruiting |
| MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020) | Milwaukee, Wisconsin, United States | Recruiting |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 0108) | Macquarie University, New South Wales, Australia | Recruiting |
| Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107) | Greenslopes, Queensland, Australia | Recruiting |
| Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110) | Melbourne, Victoria, Australia | Recruiting |
| Centre Hospitalier de l'Université de Montréal ( Site 0200) | Montreal, Quebec, Canada | Recruiting |
| Jewish General Hospital ( Site 0206) | Montreal, Quebec, Canada | Recruiting |
+ 65 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06353386