NRG-GY004

A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Principal Investigator

Joyce Liu, MD, MPH

Status

Disease Site

Gynecologic [GY] Ovarian

Phase

III

Developmental Therapeutics

No

Primary Objective

Assess the efficacy of either single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer

Patient Population

Patients have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers.  Patients with known deleterious germline BRCA1 or BRCA2 mutation on a clinical assay with an ovarian, primary peritoneal, or fallopian tube cancer of the following other Mullerian histologies are also eligible: clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma.

Target Accrual

549