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EPIK-O: A Phase III, Multi-center, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer
Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive Alpelisib + olaparib. Alpelisib will be administered at a dose of 200mg, orally, once daily. Olaparib will be administered at a dose of 200mg, orally, twice daily. In the Active Comparator Arm, participants will receive the investigator's choice of one of 2 single agent cytotoxic chemotherapies: Paclitaxel (80 mg/m2, intravenously, weekly) or Pegylated liposomal Doxorubicin (PLD) (40-50 mg/m2, intravenously, every 28 days).