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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 is a Phase 1 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 3 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05295927
The ClinicalTrials.gov registry entry for NCT05295927 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Apalutamide is the first listed.
NCT05295927 reports 0 study locations.
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.
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