Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 1 study, sponsored by Epizyme.
NCT04179864 is a Phase 1 study that was terminated before completion, run by Epizyme. The registered enrollment target is 102 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which did not necessarily had a causal relationship with this study drug. An SAE was an AE which occurred during any study phase and at any dose of study drug, that fulfilled 1 or more of following: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, was a congenital a
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 |
Why NCT04179864 stopped before completion
NCT04179864 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher).
The record links to 0 conditions, and to 3 interventions - of which Enzalutamide is the first listed.
NCT04179864 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04179864's enrollment target sits among peer trials
102 543rd of 2000 higher than 1,455 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03704662 · 102 participants · NA
Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
- NCT04174742 · 102 participants
Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
- NCT04275362 · 102 participants
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
- NCT04541082 · 102 participants · Phase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI