NRG-GY014

A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma

Principal Investigator

Ramez N. Eskander

Status

Disease Site

Gynecologic [GY] Ovarian

Phase

II

Developmental Therapeutics

No

Primary Objective

To assess the clinical activity (overall response rate) of tazemetostat in patients with recurrent or persistent endometrioid or clear cell ovarian carcinoma, and patients with recurrent or persistent endometrioid endometrial adenocarcinoma.

Patient Population

Women with pathologically proven diagnosis of recurrent or persistent ovarian clear cell carcinoma with an ARID1A mutation per NGS.

Primary or recurrent ovarian tumors must be at least 50% endometrioid or clear cell morphology.  

All patients must have measurable disease, and have had at least 1, but no more than 3, prior cytotoxic regimens for management of primary disease.

Target Accrual

86