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

This study has been terminated.
(due to absence of evidence of clinical activity up to toxic doses)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00543972
First received: October 12, 2007
Last updated: May 13, 2009
Last verified: May 2009
History of Changes
  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.


Condition Intervention Phase
Myeloid Leukemia
 Drug: AVE9633
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Incidence of Dose Limiting Toxicity(ies) at each tested dose level [ Time Frame: Study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: Study period ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: September 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AVE9633
    Intravenous Infusion
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543972

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
France
Sanofi-Aventis Administrative Office
Paris, France
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00543972     History of Changes
Other Study ID Numbers: TED10219, EudraCT 2006-005976-41
Study First Received: October 12, 2007
Last Updated: May 13, 2009
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013