Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab

Summary

This is a randomized, two-arm, open-label Phase II multicenter study designed to examine the effects of adding bevacizumab to ixabepilone for the treatment of patients who have recurrent or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Its primary objective is to assess whether adding bevacizumab to ixabepilone improves progression-free survival in its target population. Study participants will be stratified by (a) study site and (b) previous receipt of bevacizumab prior to randomization.

Timeline

Start

2017-04-03

Primary completion

2022-12-29

Completion

2022-12-29

Publications

• Results Roque DM, Siegel ER, Buza N, Bellone S, Silasi DA, Huang GS, Andikyan V, Clark M, Azodi M, Schwartz PE, Rao GG, Reader JC, Hui P, Tymon-Rosario JR, Harold J, Mauricio D, Zeybek B, Menderes G, Altwerger G, Ratner E, Santin AD. Randomised phase II trial of weekly ixabepilone +/- biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer. Br J Cancer. 2022 Jun;126(12):1695-1703. doi: 10.1038/s41416-022-01717-6. Epub 2022 Feb 11.
• Roque DM, Siegel ER, Buza N, Bellone S, Huang GS, Altwerger G, Andikyan V, Clark M, Azodi M, Schwartz PE, Rao GG, Ratner E, Santin AD. Randomized phase II trial of weekly ixabepilone +/- biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer (NCT03093155): Updated survival and subgroup analyses. BJC Rep. 2024 Jun 20;2(1):43. doi: 10.1038/s44276-024-00067-5.
• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Drugs

Indications