OncRef

Clinical Trial: NCT06104449

A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-04-27

Study Overview

Brief Summary

The purpose of this study is to assess the efficacy and safety of opevesostat in the treatment of Japanese men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Next Generation Hormonal Agent (NHA) and taxane-based chemotherapy.

Official Title

A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Conditions

Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer

Intervention / Treatment

  • Drug: Opevesostat
  • Drug: Dexamethasone
  • Drug: Fludrocortisone acetate
  • Drug: Hydrocortisone

Other Study ID Numbers

  • 5684-005
  • MK-5684-005
  • jRCT2031230431

Start Date (Actual)

2023-11-14

Primary Completion Date (Actual)

2026-02-20

Study Completion Date (Actual)

2026-04-17

Enrollment (Actual)

7

Study Type

Interventional

Phase

Phase 1