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

NCT02601937 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2024-10-03

Study results available
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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.

Conditions

  • Rhabdoid Tumors
  • INI1-negative Tumors
  • Synovial Sarcoma
  • Malignant Rhabdoid Tumor of Ovary

Interventions

DRUG

Tazemetostat

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

Sponsors & Collaborators

  • Epizyme, Inc.

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical · Ipsen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-07
Primary Completion
2021-06-19
Completion
2021-10-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601937 on ClinicalTrials.gov