Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
연구 개요
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.
- 스폰서
- 리드: 머크(MSD)
- 적응증
- Prostatic Neoplasms, Castration-Resistant
- 중재
- Opevesostat, Olaparib, Docetaxel, Cabazitaxel, Fludrocortisone acetate, Dexamethasone, Prednisone
- 목표 등록
- 220명
- 시작일
- 2024-05-20
- 완료(예정)
- 2029-01-15
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