Prostate Cancer Clinical Trial
A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer
Summary
A phase 1b/2 study to examine taz in combination with enz or abi/pred in patients with metastatic castration resistant prostate cancer
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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There are 16 Locations for this study
San Diego California, 92123, United States
Denver Colorado, 80211, United States
Port Saint Lucie Florida, 34952, United States
Rolling Meadows Illinois, 60008, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Las Vegas Nevada, 89169, United States
Bronx New York, 10461, United States
New York New York, 10065, United States
Syracuse New York, 13210, United States
Pittsburgh Pennsylvania, 15232, United States
Chattanooga Tennessee, 37404, United States
Hendersonville Tennessee, 37075, United States
Knoxville Tennessee, 37909, United States
Nashville Tennessee, 37203, United States
San Antonio Texas, 78229, United States
Kortrijk West Vlaanderen, , Belgium
Jerez De La Frontera Cadiz, , Spain
Barcelona , , Spain
Barcelona , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Pamplona , , Spain
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