Expired Study
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Bridgewater, New Jersey 08807


Purpose:

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.


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.


NCT ID:

NCT00543972


Primary Contact:

Study Director
ICD CSD
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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