Clavis Pharma ASA, has announced that is has decided to expand its pivotal Phase III CLAVELA study, investigating elacytarabine in patients with late-stage acute myeloid leukaemia (AML), in order to maximize the chances of success, the statistical power of the study has been increased from 80% to close to 90%.
The inclusion criteria have also been amended, and patients over the age of 65 with disease of poor prognosis are now eligible for study entry after only one previous treatment cycle, significantly expanding the potential first launch patient population.
The primary endpoint of survival will now be evaluated after 300 events have occurred vs. 250 events previously, and the study is expected to enrol approximately 400 patients. Top line data are now expected to be available in Q4 2012.
The CLAVELA study is a Phase III 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.
Olav Hellebø, Clavis Pharma CEO, commented: "Clavis Pharma is in a rare position for a company of our size in having two drug candidates in pivotal trials, with both expected to read out in 2012. We are committed to ensuring our trials are as robust as possible and designed to provide the clearest measure of efficacy. The next 12-18 months will be very exciting for us as we unveil results from the clinical development programmes for these novel compounds.”