Clavis Pharma ASA has 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 randomized, 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 randomized 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.
Olav Hellebø, Clavis Pharma CEO, commented: “The completion of patient recruitment for our Phase III CLAVELA study is an important achievement for Clavis Pharma and keeps us on track to report top-line efficacy data in Q1 2013. The results we have seen in the earlier Phase II trial with elacytarabine and the elacytarabine/idarubicin combination study in early stage AML patients have been encouraging, and we hope that this novel agent can become an effective new treatment option for AML patients.”