GA NCORP

NCORP Trials

Tazemetostat in Treating Patients with Recurrent Ovarian or Endometrial Cancer

Status
Temporarily Closed
Cancer Type
Ovarian Cancer
Uterine 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 or endometrial cancer that has come back (recurrent). Chemotherapy drugs, 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 OBJECTIVE:
I. 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.

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.
III. To evaluate BAF250a expression in patient samples as an indicator of ARID1A mutation status and correlation with the clinical response to study drug.

EXPLORATORY OBJECTIVES:
I. Translational Research Integrated Objective: Whether or not the patient has an ARID1A mutation. (08/13/2019)
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. Cycles 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.

Treatment Sites


 
For a complete listing of all trial sites in Georgia, please visit GeorgiaCancerInfo.org