Status:
COMPLETED
Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple Myeloma
Lead Sponsor:
Sanofi
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary Objectives: Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth fac...
Eligibility Criteria
Inclusion
- Multiple myeloma confirmed by bone marrow aspirate or biopsy
- Patient had to have relapsed and/or refractory multiple myeloma after at least 1 standard therapy, and have demonstrated disease progression
- Previous exposure to Velcade was allowed, provided no DLTs of Grade 3 or above had been observed during previous treatment (for Part 2 of the study only)
Exclusion
- Prior therapy with any IGF-1 system targeting compound
- History of allogenic stem cell transplantation in case of concomitant immunosuppressive therapy within 6 months before study entry. Patients having undergone autologous stem cell transplantation(s) may have been included in the study
- History of organ transplant and any patient receiving long term systemic immunosuppressive therapy
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01233895
Start Date
September 1 2006
End Date
September 1 2008
Last Update
November 3 2010
Active Locations (4)
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1
Sanofi-Aventis Investigational Site Number 250002
Lille, France, 59037
2
Sanofi-Aventis Investigational Site Number 250001
Nantes, France, 44093
3
Sanofi-Aventis Investigational Site Number 250003
Vandœuvre-lès-Nancy, France, 54511
4
Sanofi-Aventis Investigational Site Number 380001
Torino, Italy, 10126