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news.Genzyme has completed enrollment for a Phase II clinical trial examining the safety and effectiveness of Clolar in previously untreated, older adult patients with acute myelogenous leukemia who are unlikely to benefit from standard induction therapy.
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The Classic II trial was designed to enroll 109 patients at 20 sites in the US. Patients receive an induction cycle of intravenous clofarabine (Clolar) administered as 30mg/m2 per day for five consecutive days then, based on response, receive up to five additional cycles of treatment at a dose of 20 mg/m2 per day for five consecutive days.
The primary endpoint is overall remission rate measured as either complete remission or complete remission with incomplete platelet recovery. Secondary endpoints include duration of remission, disease free survival, overall survival, safety and thirty-day mortality rate.
Data from this study are expected to provide substantial evidence for expanding the current product label into adult acute myelogenous leukemia (AML). Genzyme has held preliminary discussions with the FDA in advance of submitting a supplemental new drug application (sNDA) for clofarabine as an initial treatment in older adults with AML. The company expects to file this sNDA in the second half of 2008.
Mark Enyedy, president of Genzyme Oncology, said: “The completion of patient enrollment in this clinical study is another important step in our plan to broaden the Clolar label to benefit a larger patient population and address multiple lines of adult AML.”