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news.Innovive Pharmaceuticals said that the first patient has been treated in a pivotal Phase II clinical trial evaluating oral tamibarotene for the treatment of refractory acute promyelocytic leukemia. This trial will be conducted under a special protocol assessment agreed upon by Innovive and FDA.
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The primary objective of the study is to determine the rate of durable complete response for tamibarotene therapy when administered as a single agent to adult patients with relapsed or refractory acute promyelocytic leukemia (APL). Secondary objectives are to determine the rates of morphologic leukemia-free state, partial response, cytogenetic complete response, and molecular complete response and to determine the safety profile, tolerability, and pharmacokinetic profile of tamibarotene in the indicated patient population.
The open-label, non-randomized, single-arm, multi-national study will enroll 50 adult patients with relapsed or refractory APL following treatment with ATRA and arsenic trioxide. Tamibarotene will be self-administered orally via tablets on an outpatient basis at a dose of 6mg/m2 per day.
In conjunction with data from Japanese studies, data from Innovive pivotal study of Tamibarotene are expected to form the basis of a new drug application with the FDA.