A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer
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.
Timeline
- Start
- 2019-11-18
- Primary completion
- 2024-11-04
- Completion
- 2024-11-04
Outcome
Outcome not reported
Stopped: “The study was terminated early as Sponsor decided to discontinue the development of tazemetostat in metastatic castration resistant prostate cancer and the primary endpoint was not met for this study. There were no safety concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tazemetostat | Small molecule | — | Oral |
| Background | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Background | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |