Clavis Pharma will expand its Phase 3 Clavela study, investigating elacytarabine in patients with late-stage acute myeloid leukaemia (AML) with the statistical power of the study increasing from 80% to 90%.
The inclusion criteria have also been amended, and patients over the age of 65 with disease of poor prognosis are eligible for study entry after only one previous treatment cycle, expanding the potential first launch patient population. The primary endpoint of survival will now be evaluated after 300 events have occurred versus 250 events previously, and the study is expected to enroll approximately 400 patients. Top line data are now expected to be available in Q4 2012.
The Clavela study is a Phase 3 open-label randomized, controlled trial comparing elacytarabine with the investigator’s choice of treatment in patients with late-stage AML. The objective is to demonstrate superiority of elacytarabine over current therapies. Patients will be randomized to each arm of the study and the difference in overall survival and other parameters will be measured.
Release Date: August 25, 2011
Source:Â Clavis Pharma
Filed Under: Drug Discovery
