BioCentury
ARTICLE | Clinical News

Vosaroxin: Completed Phase III enrollment

October 7, 2013 7:00 AM UTC

Sunesis completed enrollment of 712 patients in the double-blind, international Phase III VALOR trial comparing IV vosaroxin plus cytarabine vs. placebo plus cytarabine. The company expects to unblind the trial in 1H14 after reaching 562 events.

In September 2012, Sunesis implemented a planned sample size increase of 225 additional evaluable patients in VALOR based on an independent DSMB review of interim efficacy and safety data. The adjustment brought the target enrollment to 675 from 450 patients (see BioCentury, Sept. 17, 2012). ...