A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine
TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of
glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment
of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a
pancreatic cancer patient should receive to palliate the cancer but excludes treatment with
systemic therapies intended to kill the cancer cells.
Study Hypothesis: Glufosfamide will provide benefits in survival to patients with
metastatic pancreatic cancer over best supportive care.
Comparison: Glufosfamide versus best supportive care.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
United States: Food and Drug Administration
TH-CR-302
NCT00099294
September 2004
January 2007
Name | Location |
---|---|
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Columbia Comprehensive Cancer Care Clinic | Columbia, Missouri 65201 |
Bond Clinic | Rolla, Missouri 65401 |
Kenmar Research Institute | Los Angeles, California 90057 |
Center for Oncology Research and Treatment | Dallas, Texas 75230 |
Northern Utah Associates | Ogden, Utah 84403 |
Deaconess Billings Clinic | Billings, Montana 59107-5100 |
New Mexico Oncology Hematology Consultants | Albuquerque, New Mexico 87102 |
Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
Hematology/Oncology of the North Shore | Skokie, Illinois 60076 |
Mile High Oncology | Denver, Colorado 80210 |
Augusta Oncology Associates | Los Angeles, California 90057 |
Northwestern Connecticut Oncology - Hematology Associates | Torrington, Connecticut 06790 |
Palm Beach Institute of Hematology and Oncology | Boynton Beach, Florida 33435 |
Fort Wayne Medical Oncology/Hem | Fort Wayne, Indiana 46815 |
Norton Healthcare Center | Louisville, Kentucky 40202 |
Hattiesburg Clinic Oncology | Hattiesburg, Mississippi 39401 |
Office of Clinical Trials | Paramus, New Jersey 07652 |
Hanover Medical Specialists | Wilmington, North Carolina 28401 |
Vita Hematology Oncology PC | Bethlehem, Pennsylvania 18015 |
The Family Cancer Center , PLLC | Collierville, Tennessee 38017 |
JPS Center for Cancer Care | Fort Worth, Texas 76104 |
Cancer Outreach Association | Abingdon, Virginia 24211 |