A Randomized Phase 2 Open-Label Study of IMC-A12, as a Single Agent or in Combination With Cetuximab, in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Disease Progression on Prior Platinum-Based Chemotherapy
The routine cancer treatments for Squamous Cell Carcinoma Head and Neck Cancer have improved
but still leave a percentage of patients with incurable disease. New alternatives for
patients whose disease is refractory to existing therapies is needed.
IMC-A12 is a monoclonal antibody which binds to special receptors known as IGF-1R. This
binding action has been shown to inhibit the growth of a variety of human tumor cell lines.
The purpose of this study is to evaluation the effects of IMC-A12 by itself or with
Cetuximab (Erbitux®) in patients with Squamous Cell Carcinoma Head and Neck Cancer that has
spread to other parts of the body, and to determine how long the drug remains in the body.
The study will also look at what side effects IMC-A12 may cause when a patient is receiving
treatment.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Patient evaluation every 8 weeks until patient has Progression of Disease (PD) or dies
Evaluation every 8 weeks
No
E-mail: ClinicalTrials@ ImClone.com
Study Director
ImClone LLC
United States: Food and Drug Administration
13913
NCT00617734
March 2008
July 2012
Name | Location |
---|---|
ImClone Investigational Site | New York, New York 10021 |
ImClone Investigational Site | Bakersfield, California 93309 |
ImClone Investigational Site | Jacksonville, Florida 32207 |
ImClone Investigational Site | Atlanta, Georgia 30318 |
ImClone Investigational Site | Decatur, Illinois 62526 |
ImClone Investigational Site | Baltimore, Maryland 21204 |
ImClone Investigational Site | Minneapolis, Minnesota 55416 |
ImClone Investigational Site | Memphis, Tennessee 38104 |
ImClone Investigational Site | Dallas, Texas 75230 |
ImClone Investigational Site | Norfolk, Virginia 23502 |
ImClone Investigational Site | Philadelphia, Pennsylvania 19107 |
ImClone Investigational Site | Boston, Massachusetts 02135 |