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Small Molecule Inhibitor

EPI-7386 for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years 3 months
Awards & highlights

Study Summary

This trial is testing a new drug, EPI-7386, to see if it is safe and effective when used with other drugs to treat prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Response Rate
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs)
+1 more
Secondary outcome measures
Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Abiraterone
Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Apalutamide
Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Abiraterone
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B: EPI-3786 + ApalutamideExperimental Treatment2 Interventions
Participants with mCRPC will receive EPI-7386 + apalutamide to determine RP2D dose of EPI-7386 in combination with apalutamide in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with apalutamide.
Group II: Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP)Experimental Treatment3 Interventions
Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive EPI-7386 + AAP to determine the recommended phase 2 dose (RP2D) dose of EPI-7386 in combination with AAP in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with AAP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone Acetate
2015
Completed Phase 4
~1880
Prednisone or Prednisolone
2011
Completed Phase 3
~1260
Apalutamide
2015
Completed Phase 2
~3310

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,305 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,902 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)
2022. "A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05295927.
~1 spots leftby Apr 2025
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