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NRG-GY004

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/Co-Principal Investigator

Joyce Liu MD/Ursula Matulonis MD 

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

The target enrollment is 450 patients at approximately 180 over 2.5 years.

Status

Activation: February 4, 2016

Protocol and Other Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website




SIV memo - posted February 15, 2016
Copyright 2017 by NRG Oncology