NCT03348631

Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: 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. II. To assess the clinical activity (response frequency) of tazemetostat in patients with recurrent or persistent clear cell ovarian carcinoma with an ARID1A mutation. SECONDARY OBJECTIVES: I. To examine the nature and degree of toxicity in patients with this regimen. II. To examine the progression free survival and overall survival for this patient population receiving tazemetostat. III. To examine the 6 month clinical benefit rate in patients treated with this regimen. (20-OCT-2021) IV. To evaluate BAF250a expression in patient samples as an indicator of ARID1A mutation status and correlation with the clinical response to study drug. Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021) EXPLORATORY OBJECTIVES: I. Whether or not the patient has an ARID1A mutation. (08/13/2019) Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021) (Translational Research Integrated Objective) 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. Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021) 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. Patients also undergo computed tomography (CT) scans and magnetic resonance imaging (MRI) on study. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

• Recurrent Endometrial Endometrioid Adenocarcinoma
• Recurrent Malignant Uterine Corpus Neoplasm
• Recurrent Ovarian Carcinoma
• Recurrent Ovarian Clear Cell Adenocarcinoma
• Recurrent Ovarian Endometrioid Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
DRUG	Tazemetostat	Given PO

Timeline

• Start date: 2019-05-01
• Primary completion: 2023-07-28
• Completion: 2027-02-12
• First posted: 2017-11-21
• Last updated: 2026-04-13
• Results posted: 2025-03-06

Locations

584 sites across 1 country: United States

Regulatory

• FDA-regulated drug study