drugset / Trial / NCT03314740

Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib

NCT03314740

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer. Patients will be randomised in a 1:1:1 ratio to three treatment arms: * Arm A: Paclitaxel 80 mg/mq every week * Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day * Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks

Timeline

Start
2017-06-12
Primary completion
2021-04-01
Completion
2021-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cediranib Small molecule 20 mg Oral
Subject Olaparib Small molecule 300 mg Oral
Comparator Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications