A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
A disease assessment will be performed at study week 8 (± 3 days) by the investigator. The
assessment will be based both on changes in clinical symptoms, and radiographic images.
Subjects without evidence of disease progression may continue to receive treatment based on
their original treatment assignment until disease progression or intolerability. Disease
assessments will be performed every 8 weeks during the extended period. A safety follow-up
visit will occur 4 weeks after the last dose infusion of AGS-1C4D4 and/or gemcitabine.
Post-Treatment: Subjects terminating from protocol therapy for reasons unrelated to
documented disease progression will be followed by telephone contact every 2 months until
they begin a new anticancer therapy, their disease progresses, they die, become lost to
follow-up or withdrawal consent for further follow-up, whichever of these events occurs
first.
Overall survival: All subjects will be followed by telephone contact every 2 months until
death, loss to follow-up, or withdrawal of consent, whichever of these events occurs first.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival rate at 6 months
6 months
No
Chief Medical Officer
Study Director
Agensys, Inc.
United States: Food and Drug Administration
2008002
NCT00902291
April 2009
April 2012
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Baptist Regional Cancer Center | Knoxville, Tennessee 37920 |
University of Miami | Miami, Florida 33136 |
Annapolis Oncology Center | Annapolis, Maryland 21401 |
Palm Beach Institute of Hematology and Oncology | Boynton Beach, Florida 33435 |
Medical Oncology LLC | Baton Rouge, Louisiana 70809 |
University of California San Diego Medical Center | San Diego, California 92103-8409 |
Dana Farber Cancer Center | Boston, Massachusetts 02115 |
Virginia G. Piper Cancer Center | Minneapolis, Minnesota 55407 |
Regional Oncology Center | Syracuse, New York 13210 |
Kaiser Permanente Northwest Region Oncology Hematology | Portland, Oregon 97227 |
Vanderbilt University Medical Center, Div. of Medical Oncology | Nashville, Tennessee 37232 |
Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic | Lynchburg, Virginia 24501 |