Tazemetostat in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT03348631|
Recruitment Status : Not yet recruiting
First Posted : November 21, 2017
Last Update Posted : September 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Grade 1 Endometrial Endometrioid Adenocarcinoma Grade 2 Endometrial Endometrioid Adenocarcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Recurrent Uterine Corpus Carcinoma||Other: Laboratory Biomarker Analysis Drug: Tazemetostat||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||January 31, 2025|
|Estimated Study Completion Date :||January 31, 2025|
Experimental: Treatment (tazemetostat)
Patients receive tazemetostat PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 [ Time Frame: Up to 6 months ]
- Tumor response in patients with ARID1A mutations using tumor response as defined by RECIST v 1.1 [ Time Frame: Up to 6 months ]
- Incidence of adverse events according to grade of toxicity by organ or organ system [ Time Frame: Up to 5 years ]
- Progression-free survival [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations.
- Overall survival [ Time Frame: From study entry to time of death or the date of last contact, assessed up to 5 years ]Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348631
|Principal Investigator:||Ramez Eskander||NRG Oncology|