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news.ChemGenex Pharmaceuticals has launched a new Phase II study evaluating the use of omacetaxine mepesuccinate in refractory or relapsed acute myeloid leukemia or AML patients who have failed intensive chemotherapy.
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The study will be conducted in France and is designed as a two-stage study with potential enrolment of up to 27 patients. The primary endpoint will be the proportion of patients achieving complete and partial remissions, and the secondary endpoints will include survival.
In the induction Phase, patients will receive 2.5mg/m2 omacetaxine by subcutaneous injection twice a day for nine consecutive days, with cycles repeated every 28 days. In the maintenance Phase, patients will receive 1.25mg/m2 omacetaxine by subcutaneous injection twice a day for seven consecutive days, with cycles repeated every 28 days.
The study will be conducted in two stages, using a Simon two-stage study design. During the first stage, 13 evaluable patients will be enrolled. If one or more responses are seen during the first stage, another 14 evaluable patients will be enrolled in the second stage. It is anticipated that a maximum of 27 patients will be enrolled into the study.