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NRG-GY005

NRG-GY005:

A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

 

Principal Investigator/Co-Principal Investigator

Jung-Min Lee MD/Angeles Alvarez Secord MD, MHSc

Primary Objective Phase II

To asess the efficacy and identify (in)active arm(s) of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by PFS in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer.

Primary Objective Phase III

To assess the efficacy of the combination of cediranib and olaparib, and active monotherapy experimental arm(s) from Randomized Phase II, as measured by OS and PFS, as compared to physician's choice standard of care chemotherapy in women with recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer.

Patient Population

Patients have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer with histological diagnosis of either serous or endometrioid cancer based on local histopathological findings. Both endometrioid and serous histology will be high-grade for eligibility of non-mutation carriers. Participants with a deleterious germline BRCA-mutation on a commercial CLIA assay with other high-grade histologies, including clear cell, transitional cell, undifferentiated adenocarcinoma, mixed epithelial adenocarcinoma are also eligible.

Target Accrual

Approximately 208 patients for Phase II over about 1.6 years. Target for Phase III depends upon number of experimental regimens selected for evaluation. If warranted Phase III target 170 patients to each experimental regimen over 1.8 to 3.6 additional years.

Status

Activation: February 5, 2016

Protocol and Other Documents

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


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Copyright 2017 by NRG Oncology