drugset / Trial / NCT03314740
Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib
Phase 2
Completed
123 enrolled
Mario Negri Institute for Pharmacological Research
AstraZeneca · collab
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
Publications
- Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
- Colombo N, Tomao F, Benedetti Panici P, Nicoletto MO, Tognon G, Bologna A, Lissoni AA, DeCensi A, Lapresa M, Mancari R, Palaia I, Tasca G, Tettamanzi F, Alvisi MF, Rulli E, Poli D, Carlucci L, Torri V, Fossati R, Biagioli E; BAROCCO study group. Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer. Gynecol Oncol. 2022 Mar;164(3):505-513. doi: 10.1016/j.ygyno.2022.01.015. Epub 2022 Jan 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cediranib | Small molecule | 20 mg | Oral |
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |