OReO
Research type
Research Study
Full title
A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients with Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy (OReO)
IRAS ID
225790
Contact name
Rosalind (Ros) Glasspool
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2016-003346-90
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, days
Research summary
High grade epithelial ovarian cancer is initially sensitive to chemotherapy but the majority of women will develop progressive or recurrent disease. Their disease may respond to further chemotherapy but relapsed disease is incurable and typically the time interval between finishing chemotherapy and the cancer progressing again becomes shorter with successive treatments. However the introduction of PARP inhibitors has allowed prolonged control of disease in some women. PARP inhibitors interfere with the way tumour cells repair damage to DNA (the molecule that contains the genetic code for cells). When given as oral maintenance treatment after a response to platinum based chemotherapy for relapsed disease they prolong the time to it takes for the cancer to progress again. The greatest benefit is seen in women with hereditary (germline) mutations in the BRCA genes or in tumours with acquired (somatic) BRCA mutations. However a benefit is also seen in women without a BRCA mutation,. After ovarian cancer progresses on a PARP inhibitor, it may respond to further chemotherapy. In standard of care they would not receive a PARP inhibitor again. The aim of this study is to assess whether giving further maintenance treatment with the PARP inhibitor, olaparib, in women who whose tumour has responded to further platinum based chemotherapy after previously benefiting from a PARP inhibitor therapy, is of benefit compared to placebo (i.e. no active maintenance therapy after chemotherapy) .
The length of time that a woman was on previous PARP inhibitor treatment will be used as a measure of previous benefit. Women with BRCA mutations (germline or somatic) require to have been on PARP inhibitor treatment for at least 18 months following first line chemotherapy and 12 months following subsequent lines and women without BRCA mutations for 12 and 6 months respectively. The study is an international, multi-centre, randomised, placebo controlled study and will include approximately 416 patients.
This clinical research study is being sponsored by a pharmaceutical company, AstraZeneca, in collaboration with the European Network for Gynaecological Oncology Trials Network (ENGOT).
REC name
West of Scotland REC 1
REC reference
17/WS/0180
Date of REC Opinion
16 Oct 2017
REC opinion
Further Information Favourable Opinion