A Study of Tazemetostat (EZH2 Inhibitor) in Adult Participants With SoftTissue Sarcoma
Trial ID: NCT02601950
Phase: Phase 2
Status: Terminated
Last Verified: May 2026
Eligibility: Adults with advanced or metastatic synovial sarcoma confirmed by the SS18-SSX fusion gene. Participants must have measurable tumors and have experienced disease progression after prior therapies.
Overview: This Phase 2 trial investigated tazemetostat, an oral medication that blocks the EZH2 enzyme, which plays a role in the growth of synovial sarcoma. The study aimed to determine whether tazemetostat could slow or stop tumor growth in patients with advanced synovial sarcoma.

Results: No tumor shrinkage was observed in the synovial sarcoma patients enrolled. However, about one-third of patients saw their disease stabilize, with a smaller group maintaining that stability for four months or longer. The drug was generally well tolerated, with the most common side effects being mild
cough, shortness of breath, and fatigue.

⚠️ Important Update – FDA Approval Withdrawn (May 2026) In March 2026, the maker of tazemetostat voluntarily withdrew all FDA approvals for the drug after a clinical trial in another cancer type revealed a serious risk of developing secondary blood cancers, including leukemia and myelodysplastic syndrome, in some patients.

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More Information: clinicaltrials.gov/study/NCT02601950

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