NCT03117933

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

Randomised Phase II Trial of Olaparib, Chemotherapy or Olaparib and Cediranib in Patients With Platinum-resistant Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The trial will compare the drugs olaparib and cediranib with standard chemotherapy in 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 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' tumours will 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/BRCA status. Participants will be on trial up to 18 months.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Olaparib	Tablet, 100mg and 150mg
DRUG	Cediranib	Tablet 15mg and 20mg
DRUG	Paclitaxel	Intravenous (IV)

Timeline

• Start date: 2017-03-09
• Primary completion: 2021-03-12
• Completion: 2023-12-31
• First posted: 2017-04-18
• Last updated: 2024-01-23

Locations

14 sites across 1 country: United Kingdom