Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia

An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)

The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.

Inclusion Criteria:

• Patients with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available
• ECOG performance status 0 to 2

Exclusion Criteria:

• Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion
• Allogenic transplantation within 6 months prior to inclusion
• Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis
• Previous treatment with AVE9633
• Poor kidney, liver and bone marrow functions
• Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
• Pregnant or breast-feeding women
• Patient with reproductive potential without effective birth control methods

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.