MedTrace Logo

A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma

NCT02601950 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2025-06-22

Study results available
· View outcomes & findings →

Summary

This study will include participants with various types of cancer known as soft-tissue sarcomas.

Tissues that can be affected by soft tissue sarcomas include fat, muscle, blood vessels, deep skin tissues, tendons and ligaments.

Soft tissue cancers are rare and can occur almost anywhere in the body.

Part 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin (current front line treatment) can be tolerated (known as tolerability).

It is also designed to establish a recommended study drug dosage for the next part of the study.

Part 2 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo (dummy treatment).

Conditions

  • Malignant Rhabdoid Tumors (MRT)
  • Rhabdoid Tumors of the Kidney (RTK)
  • Atypical Teratoid Rhabdoid Tumors (ATRT)
  • Selected Tumors With Rhabdoid Features
  • Synovial Sarcoma
  • INI1-negative Tumors
  • Malignant Rhabdoid Tumor of Ovary
  • Renal Medullary Carcinoma
  • Epithelioid Sarcoma
  • Poorly Differentiated Chordoma (or Other Chordoma With Sponsor Approval)
  • Any Solid Tumor With an EZH2 GOF Mutation

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 Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-22
Primary Completion
2024-02-26
Completion
2024-02-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

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 NCT02601950 on ClinicalTrials.gov