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NCT05295927 · ClinicalTrials.gov registry record · Phase 1
A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Phase 1 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT05295927: Clinical Trial Phase 1 study, sponsored by Janssen Research & Development.
NCT05295927 is a Phase 1 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05295927, a Phase 1 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).
Primary Outcome
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Interventions
- DRUG Apalutamide
- DRUG Abiraterone Acetate
- DRUG Prednisone or Prednisolone
- DRUG EPI-7386
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-03-23 |
| Est. Completion | 2022-09-30 |
| Phase | Phase 1 |
Why NCT05295927 stopped before completion
NCT05295927 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Apalutamide is the first listed.
NCT05295927 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05295927 about?
NCT05295927 is a clinical study titled "A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)". The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor acti...
What is the current status of trial NCT05295927?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2022-03-23. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT05295927?
The interventions under investigation include: Apalutamide (DRUG), Abiraterone Acetate (DRUG), Prednisone or Prednisolone (DRUG), EPI-7386 (DRUG).
Who is sponsoring clinical trial NCT05295927?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05295927's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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