On October 7, 2014 OXiGENE reported that the first patient has been enrolled in a Phase 1b/2 clinical study that will evaluate fosbretabulin in combination with Votrient (pazopanib) in patients with recurrent ovarian cancer (Press release OXiGENE, OCT 7, 2014, View Source [SID:1234500802]).
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The randomized, controlled clinical study consists of a Phase 1b dose escalation portion with the combination of fosbretabulin and pazopanib and a Phase 2 portion comparing fosbretabulin and pazopanib versus pazopanib alone. The study is estimated to enroll up to 128 patients at sites in the United Kingdom. The primary endpoint is progression-free survival, and secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.
"This study is an important first step to evaluate the potential combination of a vascular disrupting agent (VDA) with an oral anti-angiogenic agent," said Professor Gordon Rustin, Director of Medical Oncology, Mount Vernon Cancer Centre and a chief investigator for the study. "Recent clinical data suggest that combining fosbretabulin with the anti-angiogenic agent bevacizumab may provide a complementary effect in ovarian cancer patients, and we are hopeful to see a positive result in this new study that would further advance non-chemotherapeutic treatment approaches for patients with relapsed ovarian cancer."
The study is sponsored by The Christie Hospital NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit (MAHSC-CTU) with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust). Fosbretabulin and pazopanib are being provided by OXiGENE and GlaxoSmithKline, respectively.
"The data from this trial will further the body of knowledge about fosbretabulin as part of a non-chemotherapeutic regimen in treating ovarian cancer," said Dai Chaplin, Ph.D., CEO at OXiGENE. "We are delighted to support this important study, along with others, as it provides OXiGENE an important development opportunity in Europe and delivers on our strategy to leverage collaborations that advance the clinical knowledge about fosbretabulin."