opevesostat
opevesostat: 8 clinical trials tracked.
opevesostat evidence translation
What we can confirm
8 tracked trials
What it means
What to watch
Prepared research question
What is verified about opevesostat, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 1 study sponsors
Clinical Trials (8)
A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants
Primary endpoint: Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of opevesostat
A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)
Primary endpoint: Progression-Free Survival (PFS) - All Cohorts
MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)
Primary endpoint: Efficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only
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)
Primary endpoint: Number of participants who experience one or more dose-limiting toxicities (DLTs)
A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in China Participants With Metastatic Castration-Resistant Prostate Cancer
Primary endpoint: Number of Participants Who Experience an Adverse Event (AE)
A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)
Primary endpoint: Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants
MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)
Primary endpoint: Radiographic Progression-Free Survival (rPFS)
A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Primary endpoint: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 by the Investigator