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

Primary Purpose

Breast Neoplasms

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AVE1642

Fulvestrant

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast cancer, Breast Tumors, Anti IGF-1R, Hormonosensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Outcomes

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)

Secondary Outcome Measures

Progression Free rate

Safety (TEAEs, hematology, biochemistry parameters)

Full Information

NCT ID

NCT00774878

First Posted

October 16, 2008

Last Updated

March 2, 2011

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00774878

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Terminated

Why Stopped

Company decision to discontinue the AVE1642 development program, not due to any safety or efficacy concerns

Study Start Date

October 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

Keywords

Breast cancer, Breast Tumors, Anti IGF-1R, Hormonosensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Title

Arm B

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

AVE1642

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Fulvestrant

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Progression Free rate

Time Frame

at 6 months

Title

Safety (TEAEs, hematology, biochemistry parameters)

Time Frame

study period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henri ROCHE, Professor

Organizational Affiliation

Institut Claudius Regaud (TOULOUSE - FRANCE)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Paris

Country

France

Facility Name

Sanofi-Aventis Administrative Office

City

Milano

Country

Italy

Facility Name

Sanofi-Aventis Administrative Office

City

Barcelona

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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