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NCT04179864 · ClinicalTrials.gov registry record · Phase 1
A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer
A Phase 1 study, sponsored by Epizyme.
- Terminated
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
NCT04179864 is a Phase 1 study that was terminated before completion, run by Epizyme. The registered enrollment target is 102 participants.
The verdict
NCT04179864, a Phase 1 study, was terminated before completion, sponsored by Epizyme.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
Study Summary
This is a global, multi-center, open-label, randomized phase 1b/2, active-controlled safety and efficacy study of oral administration of tazemetostat in combination with enzalutamide or abiraterone/prednisone (phase 1b) versus enzalutamide or abiraterone/prednisone alone in asymptomatic or mildly symptomatic subjects with progressive, metastatic castration-resistant prostate cancer (mCRPC) who have progressed on either abiraterone acetate, enzalutamide, or apalutamide or who are second generation anti-androgen treatment naive, and who have not received chemotherapy for mCRPC. This study is designed to determine the recommended phase 2 doses (RP2D) of tazemetostat in combination with either enzalutamide or abiraterone/prednisone, based on safety, tolerability, pharmacokinetic, pharmacodynamic, and efficacy profiles.
Interventions
- DRUG Enzalutamide
- DRUG Tazemetostat
- DRUG Abiraterone/prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2024-11-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04179864
The ClinicalTrials.gov registry entry for NCT04179864 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Epizyme, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Enzalutamide is the first listed.
NCT04179864 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04179864 about?
NCT04179864 is a clinical study titled "A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer". This is a global, multi-center, open-label, randomized phase 1b/2, active-controlled safety and efficacy study of oral administration of tazemetostat in combination with enzalutamide or abiraterone/prednisone (phase 1b) versus enzalutamide or abiraterone/prednisone alone in asymptomatic or mildly sy...
What is the current status of trial NCT04179864?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2019-11-18. Estimated completion is 2024-11-04.
What interventions are being tested in trial NCT04179864?
The interventions under investigation include: Enzalutamide (DRUG), Tazemetostat (DRUG), Abiraterone/prednisone (DRUG).
Who is sponsoring clinical trial NCT04179864?
This trial is sponsored by Epizyme, which has 16 total clinical trials registered on ClinicalTrials.gov.
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