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

Stopped early · Phase 1

Conditions studied: Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT00543972
Run by: Sanofi
People needed: 12
Starts: 2007-09-01
Expected to finish: 2008-08-01
Last updated by the study team: 2009-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office — Paris, France
Sanofi-Aventis Administrative Office — Barcelona, Spain

Full record on ClinicalTrials.gov

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