CELLO-1: A Phase 1b/2 Open-Label Study Evaluating Tazemetostat in Combination with Enzalutamide or Abiraterone/Prednisone In Chemotherapy Naïve Subjects with Metastatic Castration Resistant Prostate CancerTrial Description: 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: metastatic castration-resistant prostate cancer, metastatic prostate cancer
- Phase: I/II
- Trial ID: NCT04179864
- Protocol ID: 21-105