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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00774878
• Other study ID #: TCD10631
• Secondary ID: EudraCT Number:
• Status: Terminated
• Phase: Phase 2
• First received: October 16, 2008
• Last updated: March 2, 2011
• Start date: October 2008
• Est. completion date: November 2010

Study information

• Verified date: March 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• AVE1642
AVE1642 is administered intravenously at the dose of 8 mg/kg.
• Fulvestrant
Fulvestrant is administered as a slow intramuscular injection (just before the AVE1642 infusion when given in combination).

Locations

Country	Name	City	State
France	Sanofi-Aventis Administrative Office	Paris
Italy	Sanofi-Aventis Administrative Office	Milano
Spain	Sanofi-Aventis Administrative Office	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		6 cycles	No
Secondary	Progression Free rate		at 6 months	No
Secondary	Safety (TEAEs, hematology, biochemistry parameters)		study period	Yes