Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma
Status:
Completed
Trial end date:
2019-05-01
Target enrollment:
Participant gender:
Summary
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: planned to enroll 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 plans to include 55 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.