Trials / Terminated
TerminatedNCT04179864
A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer
CELLO-1: A Phase 1b/2 Open-Label Study Evaluating Tazemetostat in Combination With Enzalutamide or Abiraterone/Prednisone in Chemotherapy Naive Subjects With Metastatic Castration-Resistant Prostate Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Epizyme, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tazemetostat | Tazemetostat (EPZ-6438) is a selective small-molecule inhibitor of the histone-lysine methyltransferase EZH2 gene |
| DRUG | Abiraterone/prednisone | 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily in combination with prednisone 5 mg administered orally twice daily. |
| DRUG | Enzalutamide | enzalutamide 160 mg (four 40 mg capsules) orally once daily |
Timeline
- Start date
- 2019-11-18
- Primary completion
- 2024-11-04
- Completion
- 2024-11-04
- First posted
- 2019-11-27
- Last updated
- 2026-03-10
- Results posted
- 2026-03-10
Locations
24 sites across 3 countries: United States, Belgium, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04179864. Inclusion in this directory is not an endorsement.