NCT00774878

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2008

Geographic Reach
3 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 3, 2011

Status Verified

March 1, 2011

Enrollment Period

2.1 years

First QC Date

October 16, 2008

Last Update Submit

March 2, 2011

Conditions

Breast Neoplasms

Keywords

Breast cancerBreast TumorsAnti IGF-1RHormonosensitivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Progression Free rate

    at 6 months

  • Safety (TEAEs, hematology, biochemistry parameters)

    study period

Study Arms (2)

Arm A

EXPERIMENTAL
Drug: AVE1642Drug: Fulvestrant

Arm B

ACTIVE COMPARATOR
Drug: Fulvestrant

Interventions

AVE1642DRUG

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

Arm A
FulvestrantDRUG

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

Arm AArm B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Milan, Italy

Location

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AVE1642Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Henri ROCHE, Professor

    Institut Claudius Regaud (TOULOUSE - FRANCE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 3, 2011

Record last verified: 2011-03

Locations

ES(1)IT(1)FR(1)