Trials / Active Not Recruiting
Active Not RecruitingNCT06104449
A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)
A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
After approval of Protocol amendment 03, participants in the survival follow-up phase will have a final survival contact and then be discontinued from the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Opevesostat | Tablets to be taken orally. |
| DRUG | Dexamethasone | Tablets to be taken orally. |
| DRUG | Fludrocortisone acetate | Tablet to be taken orally. |
| DRUG | Hydrocortisone | Tablets to be taken orally as a recue medication. |
Timeline
- Start date
- 2023-11-14
- Primary completion
- 2026-02-20
- Completion
- 2026-04-20
- First posted
- 2023-10-27
- Last updated
- 2026-03-06
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT06104449. Inclusion in this directory is not an endorsement.