* EPIK O

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  298957

• Contact name

  Rosalind Glasspool

• Contact email

  Ros.glasspool@ggc.scot.nhs.uk

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2019-004682-40

• Clinicaltrials.gov Identifier

  NCT04729387

• Duration of Study in the UK

  3 years, 3 months, 13 days

• Research summary

  The purpose of this Phase III study is to compare how well the combination of alpelisib and olaparib works and its safety and side effects compared to standard-of-care chemotherapy in participants with platinum resistant or refractory High-grade serous ovarian cancer (HGSOC) with no germline BRCA mutation detected (gBRCAnm) irrespective of PIK3CA mutation status, a population with poor outcomes and unmet medical needs. Approximately 358 participants will be randomized between

  The treatment arms are:
  Arm 1: Alpelisib 200 mg orally once daily + olaparib 200mg orally twice daily
  Arm 2: Investigator’s choice of one of two single agent chemotherapies: Paclitaxel 80mg/m2 intravenously weekly or Pegylated Liposomal Doxorubicin 40 - 50 mg/m2 (physician's discretion) intravenously every 4 weeks

• REC name

  London - Central Research Ethics Committee

• REC reference

  21/FT/0089

• Date of REC Opinion

  17 Aug 2021

• REC opinion

  Further Information Favourable Opinion