Last updated on February 2019

Olaparib +/- Cediranib or Chemotherapy in Patients With BRCA Mutated Platinum-resistant Ovarian Cancer

Brief description of study

The trial will compare the drugs olaparib and cediranib with standard chemotherapy in BRCA1/2 mutated platinum resistant ovarian cancer. Patients will be randomised to one of three treatment groups: olaparib only, olaparib and cediranib and the control group paclitaxel. The aim is to compare efficacy of the 3 treatments and also how well each treatment is tolerated including the participants quality of life.

Detailed Study Description

Olaparib is a PARP inhibitor which targets BRCA1/2 mutated tumour cells and cediranib is an anti-angiogenic drug which reduces blood supply to the tumour, suppressing tumour viability. Phase I/II trials of both drugs have shown these are well tolerated alone or in combination in ovarian cancer.

The trial aims to compare the efficacy of the combination and of olaparib alone with paclitaxel chemotherapy and whether the olaparib/cediranib combination is better tolerated thus improving quality of life. Secondly standard paclitaxel chemotherapy must be administered weekly at hospital whereas the olaparib/cediranib combination can be administered at home potentially also improving patient quality of life.

Participants will have a BRCA1/2 mutation and their tumour be resistant to platinum based therapies. Participants will be randomised into one of the 3 treatment arms after stratification for prior PARP/anti-angiogenic treatments. Participants will be on trial up to 18 months.

Clinical Study Identifier: NCT03117933

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Royal Surrey County Hospital

Guildford, United Kingdom
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