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
  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:


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 April 16, 2014