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Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer

This study has been terminated.
(Company decision to discontinue the AVE1642 development program, not due to any safety or efficacy concerns)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00774878
First received: October 16, 2008
Last updated: March 2, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the clinical activity of AVE1642 in combination with fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of "complete response", "partial response" and "stabilization of the disease".

The additional objectives are to evaluate the safety profile of AVE1642 in combination with fulvestrant and of fulvestrant alone, to assess the rate of patients without disease progression at 6 months and the overall progression-free survival time. An evaluation of the pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also be performed.

The biological activity of treatment will be assessed on tumor biopsies, when possible The potential immunogenicity of AVE1642 will be studied


Condition Intervention Phase
Breast Neoplasms
 Drug: AVE1642
Drug: Fulvestrant
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Open Label Study Evaluating an Anti Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, AVE1642, Administered Every 4 Weeks in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Clinical benefit defined as a confirmed complete response (CR) or a confirmed partial response (PR) or a stable disease (SD)lasting at least 24 weeks (6 cycles) [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free rate [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Safety (TEAEs, hematology, biochemistry parameters) [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: October 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: AVE1642
AVE1642 is administered intravenously at the dose of 8 mg/kg.
Drug: Fulvestrant
Fulvestrant is administered as a slow intramuscular injection (just before the AVE1642 infusion when given in combination).
Active Comparator: Arm B Drug: Fulvestrant
Fulvestrant is administered as a slow intramuscular injection (just before the AVE1642 infusion when given in combination).

Detailed Description:

The study treatment will be administered until disease progression, unacceptable toxicity or patient willingness to discontinue.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-menopausal women
  • Aromatase inhibitor as the last hormonal treatment
  • Breast adenocarcinoma with positive hormone receptor
  • Measurable disease as per RECIST definition

Exclusion Criteria:

  • ECOG performance status (PS) > 2
  • Prior exposure to fulvestrant or to an anti IGF-1R compound
  • No evidence of hormonosensitivity
  • HER 2-neu positive tumor
  • More than one prior regimen of chemotherapy for metastatic disease

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: NCT00774878

Locations
France
Sanofi-Aventis Administrative Office
Paris, France
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Henri ROCHE, Professor Institut Claudius Regaud (TOULOUSE - FRANCE)
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00774878     History of Changes
Other Study ID Numbers: TCD10631, EudraCT Number: 2008-000810-54
Study First Received: October 16, 2008
Last Updated: March 2, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Breast cancer
Breast Tumors
Anti IGF-1R
Hormonosensitivity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones

ClinicalTrials.gov processed this record on May 16, 2013