This is a Phase 2, multicenter, open-label, 2-part, single-arm, 2-stage study of tazemetostat 800 mg two times a day (BID) administered orally. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat. In Part 1, 12 subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status will be treated and undergo pharmacokinetics (PK) blood sample collection after a single tazemetostat 800 mg. Part 2 will include subjects with BAP1-deficient relapsed or refractory malignant mesothelioma. Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study. Response assessment will be evaluated after 6 weeks of treatment and then every 12 weeks thereafter while on study.
A Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With Relapsed or Refractory Malignant Mesothelioma With BAP1 Loss of Function
Mesothelioma BAP1 Loss of Function
Open to people ages 18 years and up
Prior therapy(ies), if applicable, must be completed according to the criteria below prior to first dose of tazemetostat:
Has adequate hematologic (bone marrow and coagulation factors), renal, and hepatic function as defined by criteria below:
NOTE: Subjects with a history of a DVT or pulmonary embolism>3 months prior to study enrollment who are on anticoagulation therapy with low molecular weight heparin are eligible for this study.
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