NCT03314740

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

Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib (Continuous vs. Intermittent) in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Both the experimental arms (Arm B and C) will be compared with Arm A in terms of PFS. If both superior to the control (Arm A), they will be compared in terms of gastrointestinal safety.

Conditions

• Ovarian Neoplasms

Interventions

Type	Name	Description
DRUG	Paclitaxel	Comparator active compound
DRUG	Cediranib	Experimental compound
DRUG	Olaparib	Experimental compound

Timeline

• Start date: 2017-06-12
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2017-10-19
• Last updated: 2025-01-10
• Results posted: 2025-01-10

Locations

6 sites across 1 country: Italy