Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06353386 · ClinicalTrials.gov registry record · Phase 1

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)

A Phase 1 study of Prostatic Neoplasms, Castration-Resistant, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 1
Development phase
220
Enrollment target
20
Study locations

NCT06353386 is a Phase 1 study of Prostatic Neoplasms, Castration-Resistant that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 220 participants, below the 719-participant average among 10 other Prostatic Neoplasms, Castration-Resistant trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 14 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06353386, a Phase 1 study of Prostatic Neoplasms, Castration-Resistant, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 1
Development phase
220 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Prostatic Neoplasms, Castration-Resistant

Interventions

  • DRUG Docetaxel
  • DRUG Olaparib
  • DRUG Cabazitaxel
  • DRUG Opevesostat
  • DRUG Fludrocortisone acetate

Study Locations (20)

Quebec

  • Centre Hospitalier de l'Université de Montréal ( Site 0200) - Montreal
  • Jewish General Hospital ( Site 0206) - Montreal
  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207) - Québec

Region M. de Santiago

  • FALP ( Site 0301) - Santiago
  • Pontificia Universidad Catolica de Chile ( Site 0303) - Santiago
  • Bradfordhill ( Site 0300) - Santiago

California

  • UCSD Moores Cancer Center ( Site 0039) - La Jolla
  • UCLA Hematology/Oncology - Santa Monica ( Site 0044) - Los Angeles

Bogota D.C.

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406) - Bogotá
  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402) - Bogotá

Florida

  • University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051) - Miami

Maryland

  • University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049) - Baltimore

New Jersey

  • Rutgers Cancer Institute of New Jersey ( Site 0033) - New Brunswick

Ohio

  • University Hospitals Cleveland Medical Center ( Site 0043) - Cleveland

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2024-05-20
Est. Completion 2029-01-15
Phase Phase 1

Sponsor

Merck Sharp & Dohme

558 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06353386

The ClinicalTrials.gov registry entry for NCT06353386 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 719-participant average among 10 other Prostatic Neoplasms, Castration-Resistant trials with a reported enrollment target (69% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostatic Neoplasms, Castration-Resistant appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.

NCT06353386 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Quebec, Region M. de Santiago, California.

Frequently Asked Questions

What is clinical trial NCT06353386 about?

NCT06353386 is a clinical study titled "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)". 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 combinati...

What is the current status of trial NCT06353386?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2024-05-20. Estimated completion is 2029-01-15.

What conditions does trial NCT06353386 study?

This clinical trial studies the following conditions: Prostatic Neoplasms, Castration-Resistant.

What interventions are being tested in trial NCT06353386?

The interventions under investigation include: Docetaxel (DRUG), Olaparib (DRUG), Cabazitaxel (DRUG), Opevesostat (DRUG), Fludrocortisone acetate (DRUG).

Who is sponsoring clinical trial NCT06353386?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06353386 being conducted?

This trial has 20 study locations across California, Florida, Maryland, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Prostatic Neoplasms, Castration-Resistant

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Prostatic Neoplasms, Castration-Resistant

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.