A Phase I Study of Tazemetostat in Children with Recurrent or Persistent INI1-Negative Tumors or Synovial Sarcoma

Full Title

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

Purpose

Tazemetostat is an investigational drug that kills cancer cells by stopping a protein called EZH2 from working. In certain cancers, such as INI1-negative tumors and synovial sarcomas, EZH2 activity is abnormally high. Tazemetostat has been shown to slow the growth of or kill cancer cells in these tumor types.

The purpose of this study is to find the highest dose of tazemetostat that can be given safely in children with INI1-negative tumors or synovial sarcoma that have continued to grow or came back despite prior therapy. Tazemetostat is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is for patients at least 6 months old and no older than 21 years.
  • Patients must have an INI1-negative tumor or synovial sarcoma.
  • Patients must recover from the serious side effects of prior therapies before entering the study.

For more information about this study and to inquire about eligibility, please contact Dr. Neerav Shukla at 212-639-5158.

Protocol

16-065

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Locations