Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
study ends around
Principal Investigator
by Nicolaos J. Palaskas, MD, PhD (ucla)
Headshot of Nicolaos J. Palaskas
Nicolaos J. Palaskas

Description

Summary

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.

Official Title

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Keywords

Prostatic Neoplasms, Castration-Resistant, Prostatic Neoplasms, Castration-Resistant Prostatic Neoplasms, Dexamethasone, Prednisone, Fludrocortisone, Docetaxel, Olaparib, Opevesostat, Cabazitaxel, Fludrocortisone acetate, Olaparib + Opevesostat, Docetaxel + Opevesostat, Cabazitaxel + Opevesostat

Eligibility

Locations

  • UCSD Moores Cancer Center ( Site 0039) accepting new patients
    La Jolla California 92037 United States
  • UCLA Hematology/Oncology - Santa Monica ( Site 0044) accepting new patients
    Los Angeles California 90404 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT06353386
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 220 study participants
Last Updated