An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease
Secondary objectives include:
- to characterize progression-free survival
- to characterize time to progression
- to determine response duration
- to characterize the effect of study drug on health-related quality of life
- to explore the correlation of positron emission tomography (PET) scan results with
objective responses observed with conventional imaging in this patient population
- to characterize the immunogenicity response of MDX-060
- to characterize the safety of MDX-060, and
- to characterize the pharmacokinetic profile of MDX-060
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Day 50/57
No
Medarex Medical Monitor
Study Director
Medarex
United States: Food and Drug Administration
MDX060-05/05E
NCT00284804
November 2005
October 2009
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Mount Sinai School of Medicine | New York, New York 10029 |
Rush Cancer Institute | Chicago, Illinois 60612 |
Henry Ford Health System | Detroit, Michigan 48202 |
Roswell Park Cancer Center | Buffalo, New York 14263 |
Mary Babb Randolph Cancer Center | Morgantown, West Virginia 26506 |
California Oncology of the Central Valley | Fresno, California 93710 |
The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Nevada Cancer Institute | Las Vegas, Nevada 89135 |
City of Hope, National Medical Center | Duarte, California 91010 |
University of California, San Diego/Moores UCSD Cancer Center | LaJolla, California 92093-0698 |
H. Lee Moffitt Cancer & Research Institute | Tampa, Florida 33612 |
St. Francis Hospital Center | Beech Grove, Indiana 46107 |
American Health Network of Indiana | Indianapolis, Indiana 46237 |
Division of Hematology/Oncology, Tufts-New England Medical Center | Boston, Massachusetts 02111 |
Carolina BioOncology Institute, PLLC | Huntersville, North Carolina 28078 |
M.D. Anderson Cancer Center, The University of Texas | Houston, Texas 77030 |