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

NCT ID: NCT00774878

Last Updated: 2011-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-11-30

Brief 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

Detailed Description

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

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Group Type: EXPERIMENTAL

AVE1642

Intervention Type: DRUG

AVE1642 is administered intravenously at the dose of 8 mg/kg.

Fulvestrant

Intervention Type: DRUG

Fulvestrant is administered as a slow intramuscular injection (just before the AVE1642 infusion when given in combination).

Arm B

Group Type: ACTIVE_COMPARATOR

Fulvestrant

Intervention Type: DRUG

Fulvestrant is administered as a slow intramuscular injection (just before the AVE1642 infusion when given in combination).

Interventions

AVE1642

AVE1642 is administered intravenously at the dose of 8 mg/kg.

Intervention Type: DRUG

Fulvestrant

Fulvestrant is administered as a slow intramuscular injection (just before the AVE1642 infusion when given in combination).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Henri ROCHE, Professor

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud (TOULOUSE - FRANCE)

Locations

Sanofi-Aventis Administrative Office

Paris, , France

Sanofi-Aventis Administrative Office

Milan, , Italy

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Countries

France; Italy; Spain

Other Identifiers

EudraCT Number: 2008-000810-54

Identifier Type: -

Identifier Source: secondary_id

TCD10631

Identifier Type: -

Identifier Source: org_study_id