This Phase I/II study was a multicenter study, performed in
8 patients with refractory acute myeloid leukemia. The treatment
schedule was 3 consecutives dosing from day 1 to day 3. The
treatment was administered by 1 hour IV infusion. Three dose
levels were assessed: 3 x 50 mg/m2 (2 patients), 3 x 35
mg/m2 (3 patients) and 3 x 65 mg/m2 (3 patients) according
to a sequential Bayesian methodology. The study was stopped
due to the pharmacokinetic profile which indicated that 3 consecutive
daily infusions was not favorable to drug elimination.
