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

Myeloid Leukemia Clinical Trial

Official title:

An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myeloid Leukemia

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