A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer
Stopped early · Phase 1/Phase 2
Conditions studied: Metastatic Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT04179864
- Run by
- Epizyme, Inc.
- People needed
- 102
- Starts
- 2019-11-18
- Expected to finish
- 2024-11-04
- Last updated by the study team
- 2026-03-10
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Age at the time of consent ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix
- Life expectancy of > 3 months.
- Histologically or cytologically confirmed adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
- Progressive disease in the setting of medical or surgical castration (ie, castration- resistant prostate cancer [CRPC]) by PCWG3 criteria for study entry.
- Evidence of disease progression by rising PSA or
- Soft tissue progression per RECIST 1.1 or
- Evidence of disease progression by observation of 2 new bone lesions since the initiation of last systemic therapy.
- Metastatic prostate cancer disease, documented by the following imaging
- Bone lesions on bone scan (per PCWG3) or by soft tissue disease (per RECIST 1.1) by CT/MRI imaging Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist.
- Prior treatment with a second-generation androgen inhibitor as follows:
- For phase 1b, EITHER Previously untreated with or progressed on a second generation androgen inhibitor (abiraterone, enzalutamide, or apalutamide) OR progressed on a second generation inhibitor (inhibitor (abiraterone, enzalutamide, or apalutamide)
- For phase 2 randomized component (i.e, enzalutamide- containing treatment arms) of the study, previously progressed on abiraterone.
You may not qualify if…
- Known symptomatic brain metastases
- Treatment with any of the following for prostate cancer within the indicated timeframe prior to day 1 of starting study treatment:
- First generation: AR antagonists (eg, bicalutamide, nilutamide, flutamide) within 4 weeks.
- 5-alpha-reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol), or progesterones within 2 weeks.
- Chemotherapy (except as permitted in inclusion criteria #10) within 3 weeks.
- Prior radionuclide therapy within 4 weeks.
- Another interventional product or standard agent in a clinical study within 28 days prior to the first planned dose of Tazemetostat
- For phase 2 subjects to be randomized to one of the enzalutamide treatment arms only, prior treatment with the second-generation androgen antagonist including enzalutamide, apalutamide, darolutamide, and proxalutamide, etc.
- Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment
- Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2.
Where it is running
- Genesis Healthcare Partners — San Diego, California, United States
- The Urology Center Of Colorado — Denver, Colorado, United States
- Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
- XCancer - Northwest Oncology and Hematology — Rolling Meadows, Illinois, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Comprehensive Cancer Centers of Nevada - Central Valley — Las Vegas, Nevada, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Associated Medical Professionals of NY, PLLC - Urology — Syracuse, New York, United States
- Montefiore Einstein Center for Cancer Care — The Bronx, New York, United States
- University of Pittsburgh Medical Center - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
- SCRI - Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States
- Urology Associates P.C. — Hendersonville, Tennessee, United States
- XCancer - Tennesee Cancer Specialists — Knoxville, Tennessee, United States
- SCRI - Tennessee Oncology Nashville — Nashville, Tennessee, United States
- Urology San Antonio — San Antonio, Texas, United States
- Academisch Ziekenhuis Groeninge Campus Kennedylaan — Kortrijk, West Vlaanderen, Belgium
- Hospital Universitario de Jerez de la Frontera — Jerez de la Frontera, Cadiz, Spain
- Hospital de la Santa Creu i. Sant Pau — Barcelona, Spain
- Hospital del Mar Parc de Salut Mar — Barcelona, Spain
- Hospital Clinico San Carlos — Madrid, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Hospital Universitario La Paz — Madrid, Spain
- Clinica Universidad de Navarra — Pamplona, Spain
Full record on ClinicalTrials.gov
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