Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353386
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-03
Brief Title:
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
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
MK-5684-01A Substudy A Phase 12 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-5684-01A | OTHER | None | None |
| 2023-506288-33 | REGISTRY | None | None |
| U1111-1292-6912 | OTHER | UTN | None |