Maintenance therapy following chemotherapy of relapsed ovarian cancer: a randomised placebo-controlled phase II trial with the angiogenesis inhibitor BIBF 1120


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Gordon Rustin1, Jonathan Ledermann2, Alan Hackshaw3, Stan Kaye4, Gordon Jayson5, Hani Gabra6, Lindsey James3, Susan Bell7, Graham Temple7

1Mount Vernon Cancer Centre, Northwood, Middlesex, UK, 2University College London Hospitals, UK, 3CR-UK & University College London Cancer Trials Centre, UK, 4Royal Marsden Hospital, London, UK, 5Christie Hospital, London, UK, 6Hammersmith Hospital, London, UK, 7Boehringer Ingelheim Ltd, Bracknell, UK

Abstract

Background

A novel trial design of maintenance therapy was used to evaluate BIBF1120, a triple angiokinase inhibitor targeting VEGFR, PDGFR and FGFR involved in the formation of blood vessels.

Method

Continuous BIBF1120 (250 mg, oral, twice daily) for up to 36 weeks (wk) was compared with placebo in a randomised double-blind trial. To be eligible patients had to have responded to their last