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

Phase 1

Terminated

• Conditions: Myeloid Leukemia

• Registration Number: NCT00543972
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-12
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-13
• Last Update Posted: 2009-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of Dose Limiting Toxicity(ies) at each tested dose level	Study period

Secondary Outcome Measures

Name	Time	Method
Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance	Study period
Incidence of Adverse Events	Study period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain