Low Dose Cyclophosphamide +/-- Nintedanib in Advanced Ovarian Cancer

Summary

The primary objective is to explore the efficacy and safety of an all oral combination of BIBF 1120 (an inhibitor of angiogenic signalling) and metronomic cyclophosphamide in patients with multiply-relapsed advanced ovarian cancer, who have completed a minimum of two lines of previous chemotherapy and who for any reason are not suitable for further 'standard' intravenous chemotherapy treatments.

Timeline

Start

2014-08

Primary completion

2018-01-11

Completion

2018-01-11

Outcome

Missed primary endpoint

paper The median OS was 6.8 (nintedanib) versus 6.4 (placebo) months (hazard ratio 1.08; 95% confidence interval 0.72-1.62; P = 0.72). PMID 33077258 ↗

Publications

• 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.
• Hall MR, Dehbi HM, Banerjee S, Lord R, Clamp A, Ledermann JA, Nicum S, Lilleywhite R, Bowen R, Michael A, Feeney A, Glasspool R, Hackshaw A, Rustin G. A phase II randomised, placebo-controlled trial of low dose (metronomic) cyclophosphamide and nintedanib (BIBF1120) in advanced ovarian, fallopian tube or primary peritoneal cancer. Gynecol Oncol. 2020 Dec;159(3):692-698. doi: 10.1016/j.ygyno.2020.09.048. Epub 2020 Oct 16.

Drugs

Indications