A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent Endometrioid / Clear Cell Carcinoma of the Ovary or Peritoneum, and Recurrent Low Grade Endometrioid Endometrial Adenocarcinoma
18 Years and older, Female
This phase II trial studies how well tazemetostat works in treating patients with ovarian, primary peritoneal, or endometrial cancer that has come back. Drugs used in chemotherapy, such as tazemetostat, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
I. To assess the clinical activity (overall response rate) of tazemetostat in patients with recurrent or persistent endometrioid or clear cell ovarian or primary peritoneal cancer, and low grade endometrioid endometrial adenocarcinoma.
I. To examine the nature and degree of toxicity in this patient population treated with this regimen.
II. To examine the progression free survival and overall survival for this patient population receiving tazemetostat.
I. To evaluate BAF250a expression in patient samples as an indicator of ARID1A mutation status and correlation with clinical response to study drug.
II. To examine the correlation between ARID1A mutation and BAF250a expression and to identify potential mutations predictive of response in patients with preserved BAF250a expression.
Patients receive tazemetostat orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.