CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 109 enrolled
Drug / intervention
Tazemetostatdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02601937
NCT02601937Phase 1Completed
CompareCT.gov

A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Epizyme, Inc.·interventional·Posted Nov 11, 2015·Updated Oct 3, 2024

In Brief

A Phase 1 clinical trial evaluating Tazemetostat for Rhabdoid Tumors and 3 related conditions. Completed, enrolled 109 participants across 35 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhabdoid Tumors, INI1-negative Tumors, Synovial Sarcoma, Malignant Rhabdoid Tumor of Ovary
CountriesAustralia, Canada, Denmark, France, Germany, Italy, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 11, 2015
Enrollment StartJan 7, 2016
Primary CompletionJun 19, 2021
Study CompletionOct 22, 2021
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 10.6 years ago

Interventions

Tazemetostatdrug

Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.