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Tazemetostat in Treating Patients with Recurrent Ovarian or Endometrial Cancer


Active: No
Cancer Type: Ovarian Cancer
Uterine Cancer
NCT ID: NCT03348631
Trial Phases: Phase II Protocol IDs: NRG-GY014 (primary)
NRG-GY014
NCI-2017-02147
Eligibility: 18 Years and older, Female Study Type: Treatment
Study Sponsor: NRG Oncology
NCI Full Details: http://clinicaltrials.gov/show/NCT03348631

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 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.

Treatment Sites in Georgia

Augusta University Medical Center
1120 15th Street
Augusta, GA 30912
706-721-4430
www.augustahealth.org



Curtis and Elizabeth Anderson Cancer Institute at Memorial University Medical Center
4700 Waters Avenue
Savannah, GA 31404
912-350-8913
www.memorialhealth.com/anderson-cancer-institute.aspx



Summit Cancer Care at the Nancy N. Lewis and J.C. Lewis Cancer & Research Pavilion
225 Candler Drive
Suite 300
Savannah, GA 31405
www.summitcancercare.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.