OPINION, Olaparib Maintenance Monotherapy Ovarian Cancer.

• Research type

  Research Study

• Full title

  OPINION - A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed non- Germline BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy

• IRAS ID

  233922

• Contact name

  Jonathan Ledermann

• Contact email

  j.ledermann@ucl.ac.uk

• Sponsor organisation

  Astra Zeneca AB

• Eudract number

  2017-002767-17

• Duration of Study in the UK

  2 years, 6 months, 16 days

• Research summary

  This study is assessing the efficacy and safety of olaparib as a maintenance treatment in patients with relapsed High Grade Serious Ovarian Cancer(including patients with primary peritoneal or Fallopian tube cancer) or high grade endometrioid cancer, who do not have known deleterious or suspected deleterious germline BRCA mutations (nongBRCAm) and who have responded to platinum based chemotherapy. Patients will be followed up regularly until disease progression and start of first subsequent therapy.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  18/LO/0141

• Date of REC Opinion

  15 Feb 2018

• REC opinion

  Favourable Opinion