EPI-7386 for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate Cancer
EPI-7386 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Study Objectives

4 Primary · 13 Secondary · Reporting Duration: Up to 3 Years 3 Months

At 12 weeks
Composite Response Rate
Day 28
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
Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Apalutamide
Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Abiraterone
Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Apalutamide
Minimum Observed Serum Concentration (Cmin) of EPI-7386 and Abiraterone
Minimum Observed Serum Concentration (Cmin) of EPI-7386 and Apalutamide
Observed Accumulation Index Based on Cmax (ARCmax) of EPI-7386 and Abiraterone
Observed Accumulation Index Based on Cmax (ARCmax) of EPI-7386 and Apalutamide
Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and Abiraterone
Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and apalutamide
Day 28
Number of Participants with Dose-limiting Toxicities (DLT)
Year 3
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs)
Serum Prostate-Specific Antigen (PSA)

Trial Safety

Trial Design

2 Treatment Groups

Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP)
1 of 2
Group B: EPI-3786 + Apalutamide
1 of 2
Experimental Treatment

82 Total Participants · 2 Treatment Groups

Primary Treatment: EPI-7386 · No Placebo Group · Phase 1

Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP)Experimental Group · 3 Interventions: EPI-7386, Abiraterone Acetate, Prednisone or Prednisolone · Intervention Types: Drug, Drug, Drug
Group B: EPI-3786 + ApalutamideExperimental Group · 2 Interventions: EPI-7386, Apalutamide · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone Acetate
2015
Completed Phase 4
~1350
Prednisone or Prednisolone
2011
Completed Phase 3
~1260
Apalutamide
2015
Completed Phase 2
~490

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years 3 months

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
918 Previous Clinical Trials
6,327,084 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
707 Previous Clinical Trials
3,900,062 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Use of contraception should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies.
You are willing and able to comply with the requirements of this protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.