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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Oct 2025

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At a glance

  • Drugs Alpelisib (Primary) ; Olaparib (Primary) ; Doxorubicin liposomal; Paclitaxel
  • Indications Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms EPIK-O
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 20 Oct 2025 Planned End Date changed from 6 Dec 2025 to 5 Dec 2025.
  • 08 Sep 2025 Planned End Date changed from 4 Jun 2025 to 6 Dec 2025.
  • 23 Jan 2025 Planned End Date changed from 31 Jan 2026 to 4 Jun 2025.

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