A Phase 2, Multicenter, Randomized Study of IMC-A12 or IMC-1121B Plus Mitoxantrone and Prednisone in Metastatic Androgen-Independent Prostate Cancer (AIPC) Following Disease Progression on Docetaxel-Based Chemotherapy
Prostate cancer is the most frequently diagnosed cancer in men and the second leading cause
of cancer-related death in men in the United States. Chemotherapy, either as a single agent
or in combination, may lead to clinical response, pain control, and/or improved quality of
life. Docetaxel is now the first-line standard therapy for AIPC. Mitoxantrone was approved
in 1996 for use in combination with corticosteroids as initial chemotherapy for pain related
to advanced HRPC. Hormonal manipulations and docetaxel-based chemotherapy are often
effective in metastatic prostate cancer; however, disease becomes refractory to these
interventions in the majority of men. Although mitoxantrone continues to be a significant
agent in the treatment of HRPC, there exists a need for more efficacious therapy in
docetaxel-refractory- AIPC. Because of the potential contribution of IGF-IR and VEGFR-2
mediated pathways in prostate cancer pathogenesis, it is hypothesized that each of these
biological agents in combination with mitoxantrone and prednisone will result in clinically
meaningful activity in AIPC. Therefore, ImClone plans to conduct a randomized Phase 2 trial
to assess the safety and efficacy of IMC-A12 or IMC-1121B (ramucirumab) in combination with
mitoxantrone and prednisone in patients with AIPC.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
37 months
No
E-mail: ClinicalTrials@ ImClone.com
Study Director
ImClone LLC
United States: Food and Drug Administration
13924
NCT00683475
August 2008
September 2011
Name | Location |
---|---|
ImClone Investigational Site | Greenwich, Connecticut 06830 |
ImClone Investigational Site | New York, New York 10021 |
ImClone Investigational Site | St. Charles, Missouri 63301 |
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 | New Orleans, Louisiana 70121 |
ImClone Investigational Site | Ypsilanti, Michigan 48198 |
ImClone Investigational Site | Minneapolis, Minnesota 55416 |
ImClone Investigational Site | Great Falls, Montana 59405 |
ImClone Investigational Site | Voorhees, New Jersey 08043 |
ImClone Investigational Site | Cleveland, Ohio 44134 |
ImClone Investigational Site | Greenville, South Carolina 29605 |
ImClone Investigational Site | Memphis, Tennessee 38104 |
ImClone Investigational Site | Dallas, Texas 75230 |
ImClone Investigational Site | Green Bay, Wisconsin 54307 |
ImClone Investigational Site | Winston-Salem, North Carolina 27103 |
ImClone Investigational Site | Philadelphia, Pennsylvania 19107 |
ImClone Investigational Site | Seattle, Washington 98104 |
ImClone Investigational Site | Cedar Rapids, Iowa 52402 |