Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Brief Summary:
This is a Phase I, open-label, dose escalation and dose expansion study with a BID oral dose of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study.
The study has two parts: Dose Escalation and Dose Expansion.
Dose escalation for subjects with the following relapsed/refractory malignancies:
Dose Expansion at the MTD or the RP2D, for subjects with rhabdoid tumors (MRT/ATRT/RTK/selected tumors with rhabdoid features).