A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)

NCT06136598 on ClinicalTrials.gov Phase 1 Merck Sharp & Dohme LLC (industry) Started 2024-01-30 Completed

Riskier than 38% of active trials

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,938 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2026-03-09, after 2024-01-30 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2026-03-09. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Sponsor's past termination rate: 16.4% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cancermetastaticchemotherapyhas historytherapy
Phrases that lowered it: prostateparticipantscastrationto evaluateevaluate the
Sponsor's past trials: 1478 (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 131 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Drug's FAERS reports with a death: 15.3% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 82.6% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports before start: 403967 (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 37038 (lowers risk) · Drug's FDA history
Responsible party: sponsor (lowers risk) · Design
Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (typical: 71)
Sex: male (typical: all)
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 1478 (typical: 32)
Sponsor's past termination rate: 16.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 131 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 403967 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 37038 (typical: 412.5)
Drug's FAERS reports marked serious: 82.6% (typical: 85.6%)
Drug's FAERS reports with a death: 15.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: dexamethasone, fludrocortisone, hydrocortisone

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005) NCT06104449 · started 2023 · scored riskier than 38% of active trials completed
A Study Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch NCT03778047 · started 2018 · scored riskier than 22% of active trials completed
A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer NCT05673109 · started 2023 · scored riskier than 16% of active trials terminated
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China Extension NCT04907227 · started 2020 · scored riskier than 43% of active trials terminated
Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) NCT04631601 · started 2021 · scored riskier than 48% of active trials terminated

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.