![]() ![]() VALOR enrollment initiated in December 2010. ![]() ![]() VALOR ( NCT01191801) is a phase III, randomized, controlled, double-blind, multinational trial of the efficacy and safety of vosaroxin and cytarabine versus placebo and cytarabine in patients with first relapsed or refractory AML OS is the primary endpoint. Vosaroxin (formerly voreloxin) with cytarabine had a promising activity/tolerability profile in phase II in this population (N=69): median OS 7.1 mos, combined CR rate 29%, current median leukemia-free survival 14.4 mos, 30-day all-cause mortality 3% (Stuart Chem Found Symp 2010), supporting phase III trial design. Background: Median overall survival (OS) for patients with relapsed or refractory AML remains short (3-6 mos) with current treatments. ![]()
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