NRG-GY005: Platinum-Resistant
• Recurrent HGSC with PFI <6 months (following most recent platinum)
• No more than 2 prior treatment regimens (including primary therapy)
• RECIST measurable or evaluable disease, biopsy accessible
• No prior PARPi therapy, prior bevacizumab permitted
• Stratify for BRCA status, number of prior treatment regimens
• Primary endpoint: OS 90% Power with HR 0.625
Open:
FEB 2106
Closed:
(ongoing) n=53 as of 14OCT2016
Target Accrual:
460 pts (135 BRCA1/2 +)
Lee J-M, for GOG
Cediranib (PO)
Olaparib (PO)
Cediranib + Olaparib (PO)
R
Randomized Phase II (n = 180)
Selected Regimen (PO)
Non-Platinum Chemo* (IV)
R
Randomized Phase III (n = 280)
* Weekly paclitaxel or PLD
1:1
Non-Platinum Chemo* (IV)
