Clavis Pharma completes patient recruitment in Phase III study with elacytarabine in patients with acute myeloid leukaemia
Clavis Pharma ASA announced that is has reached the enrolment target for its Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukaemia (AML). Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine, which is routinely used in the treatment of AML.
The CLAVELA study is a 380-patient Phase III open-label randomised, controlled trial comparing elacytarabine with the investigator’s choice of treatment in patients with relapsed or refractory AML. The study is being conducted at 76 clinical sites in the USA, Canada, Europe and Australia. The primary endpoint of the study is overall survival (OS) and the objective is to demonstrate superiority of elacytarabine over current therapies. Patients have been randomised to each arm of the study and the difference in OS and other parameters, including response rates, duration of response, and safety profile of elacytarabine, will be measured. Top-line data are expected to be available in Q1 2013.
Other news from the department research and development
