EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

NCT02601937 ↗

Phase 1 Completed 109 enrolled Epizyme, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of the enhancer of zeste homolog-2 (EZH2) inhibitor, 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.

Timeline

Start: 2016-01-07
Primary completion: 2021-06-19
Completion: 2021-10-22

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tazemetostat	Small molecule	240 mg/m2	Oral
Subject	Tazemetostat	Small molecule	300 mg/m2	Oral
Subject	Tazemetostat	Small molecule	400 mg/m2	Oral
Subject	Tazemetostat	Small molecule	520 mg/m2	Oral
Subject	Tazemetostat	Small molecule	700 mg/m2	Oral
Subject	Tazemetostat	Small molecule	800 mg/m2	Oral
Subject	Tazemetostat	Small molecule	900 mg/m2	Oral
Subject	Tazemetostat	Small molecule	1200 mg/m2	Oral

EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Summary

Timeline

Drugs

Indications