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Trial Summary

The objective of this study is to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.

Acronym:

EPIK-O

ACTRN/NCT /ethics:

NCT04729387

Scientific title:

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

Sponsor / Cooperative group:

Novartis Pharmaceuticals

Trial & Patient Characteristics

Cancer TypeGynaecological
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexFemale
Tumour Stream =
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2021-07-02
Anticipated End Date2023-03-02

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorHannah Adelson
EmailHannah.adelson@sa.gov.au
Phone08 8206 4835
Principal InvestigatorDr Shawgi Sukumaran
Recruitment StatusRecruiting