A Phase II Study of Tazemetostat in Patients with Persistent or Recurrent Synovial Sarcomas or Tumors Lacking the INI1 or SMARCA4 Genes

Full Title

A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

Purpose

Tazemetostat is an investigational drug that kills cancer cells by stopping a gene called EZH2 from working. EZH2 affects how two other genes, INI1 and SMARCA4, work in cells. Tazemetostat has been shown to slow the growth of or kill cancer cells that don't contain the INI1 or SMARCA4 genes.

The purpose of this study is to evaluate the safety and effectiveness of tazemetostat in synovial sarcomas that have continued to grow or came back despite prior therapy and in advanced cancers lacking the INI1 or SMARCA4 genes. 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:

  • Patients must have persistent or recurrent synovial sarcoma or an advanced solid tumor that lacks the INI1 or SMARCA4 genes. Examples include rhabdoid tumors of the kidney, ovary, and other sites and certain rare epithelial tumors.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 16 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mrinal Gounder at 646-888-4167.

Protocol

15-328

Phase

II

Investigator

Co-Investigators

Locations