Georgia's Online Cancer Information Center

Find A Clinical Trial

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

Status
Temporarily Closed
Cancer Type
Endometrial Cancer
Ovarian Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Female
Study Type
Treatment
NCD ID
NCT03348631
Protocol IDs
NRG-GY014 (primary)
NRG-GY014
NCI-2017-02147
Study Sponsor
NRG Oncology

Summary

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.

Objectives

PRIMARY OBJECTIVES:
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.

SECONDARY OBJECTIVES:
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.

TERTIARY OBJECTIVES:
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.

OUTLINE:
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.
Georgia CORE

 

Hearts and Minds Dedicated to Improving Cancer Care

Georgia CORE is a public-private partnership that creates collaboration among the state’s cancer organizations and institutions to connect more Georgians to quality, personalized cancer care. We welcome you to this one-of-a-kind online information center for all things related to cancer and survivorship care in Georgia.