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

Phase 2

Terminated

• Conditions: Breast Neoplasms
• Interventions: Drug: AVE1642; Drug: Fulvestrant

• Registration Number: NCT00774878
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-02
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	AVE1642	-
Arm B	Fulvestrant	-
Arm A	Fulvestrant	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Progression Free rate	at 6 months
Safety (TEAEs, hematology, biochemistry parameters)	study period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain