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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00543972
Other study ID # TED10219
Secondary ID EudraCT 2006-005
Status Terminated
Phase Phase 1
First received October 12, 2007
Last updated May 13, 2009
Start date September 2007
Est. completion date August 2008

Study information

Verified date May 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
AVE9633
Intravenous Infusion

Locations

Country Name City State
France Sanofi-Aventis Administrative Office Paris
Spain Sanofi-Aventis Administrative Office Barcelona
United States Sanofi-Aventis Administrative Office Bridgewater New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Dose Limiting Toxicity(ies) at each tested dose level Study period Yes
Secondary 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 No
Secondary Incidence of Adverse Events Study period Yes
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