A Phase I/II Clinical Trial of PXD101 in Combination With Idarubicin in Patients With AML Not Suitable for Standard Intensive Therapy
This trial is an open-label, multi-centre, dose-escalation Phase I/II study to evaluate
safety, explore efficacy, pharmacodynamics, and pharmacokinetics of the combination of
PXD101 with idarubicin administered in two different schedules in patients with AML. The
PXD101 plus idarubicin treatment will be repeated at suitable intervals (target is every 3
weeks for schedule A and every 2 weeks for schedule B) depending upon toxicities or disease
progression. Safety and efficacy assessments will be performed at every cycle.
Schedule A uses PXD101 by 30 min infusion daily for 5 days every 3 weeks with escalating
doses of idarubicin.
Schedule B uses escalating doses of continuous infusion (48h) of PXD101 alone or in
combination with idarubicin.
In both regimens the trial may be expanded at the Maximum Tolerated Dose (MTD).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety and tolerance (Maximum Tolerated Dose, Dose Limiting Toxicity) and efficacy (Response rate (CR or PR))
Hervé Dombret, MD
Hôpital St. Louis, Paris, France
United States: Food and Drug Administration