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

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.