Phase 2 Trial of Niraparib or Niraparib and Bevacizumab Combination in Patients with Recurrent Endometrial and/or Ovarian Cancer with ARID1A Mutation (OU-SCC- ARID1A)

UVA Tracking #
HSR230456
Principal Investigator
Paola A Gehrig
Contact
Contact Phone
Official Trial Title
Phase 2 Trial of Niraparib or Niraparib and Bevacizumab Combination in Patients with Recurrent Endometrial Cancer and/or Ovarian Cancer with ARID1A Mutation (OU-SCC- ARID1A)
Study Description

The University of Virginia seeks adults ages 18 and over with Recurrent Endometrial and/or Ovarian Cancer with an ARID1A Mutation for a research study of an investigational treatment.

The primary goal of this study is:
• To estimate the proportion of patients with recurrent endometrial or ovarian cancer with mutated ARID1A, who have objective tumor response (complete or partial), to the combination treatment of niraparib and bevacizumab and to monotherapy niraparib.
All eligible participants will receive either niraparib alone or niraparib plus bevacizumab. This trial will last for approximately 72 months allowing for patients to enroll, receive treatment, have post-treatment follow-up, and data analysis.

This study involves blood sampling, tumor biopsies, an electrocardiogram (ECG), various examinations, and a CT or MRI. The study drug(s) will be either taken orally (niraparib) or infused (bevacizumab).

Participant’s insurance company will be billed for medication, tests and procedures. The study drug Niraparib will be provided by the sponsor for this study (GSK).

Phase 2 Trial of Niraparib or Niraparib and Bevacizumab Combination in Patients with Recurrent Endometrial and/or Ovarian Cancer with ARID1A Mutation

Compensation

No Compensation