Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT03348631|
Recruitment Status : Suspended (Scheduled Interim Monitoring)
First Posted : November 21, 2017
Last Update Posted : January 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma Recurrent Endometrial Endometrioid Adenocarcinoma Recurrent Ovarian Carcinoma Recurrent Ovarian Clear Cell Adenocarcinoma Recurrent Ovarian Endometrioid Adenocarcinoma Recurrent Uterine Corpus Cancer||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 carcinoma, and patients with recurrent or persistent 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.
III. To evaluate BAF250a expression in patient samples as an indicator of ARID1A mutation status and correlation with the clinical response to study drug.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 29, 2019|
|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. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Tumor response [ Time Frame: Up to 6 months ]Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
- Tumor response in patients with ARID1A mutations using tumor response [ Time Frame: Up to 6 months ]Will be defined by RECIST v 1.1.
- Incidence of adverse events [ Time Frame: Up to 5 years ]Will be assessed according to grade of toxicity by organ or organ system.
- 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.
- ARID1A mutational status [ Time Frame: Up to 6 months ]Associations between BAF250a and ARID1A mutations may be examined with contingency table analysis (e.g. potentially including Chi-square analyses or Spearman's correlation).
- BAF250a expression [ Time Frame: Up to 6 months ]Will be assessed by immunohistochemistry. Associations between BAF250a and ARID1A mutations may be examined with contingency table analysis (e.g. potentially including Chi-square analyses or Spearman's correlation).
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 N Eskander||NRG Oncology|