A Phase Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic Cancer.
Patients receive a 4-week treatment cycle with once-weekly 30-minute gemcitabine infusions
beginning one week prior to the first 90Y-hPAM4dose and continuing during the 3 consecutive
weeks over which once weekly 90Y-hPAM4 doses are given. Depending on toxicity, patient
cohorts will receive one of several possible 90Y and gemcitabine dose combinations.
Post-treatment evaluations conducted until instituting another 90YhPAM4 treatment cycle,
maintenance gemcitabine or for a maximum period of 12 weeks.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity
over 12 weeks
Yes
William Wegener, MD, PHD
Study Chair
Immunomedics, Inc.
United States: Food and Drug Administration
IM-T-hPAM4-02
NCT00603863
January 2008
December 2014
Name | Location |
---|---|
University of North Carolina | Chapel Hill, North Carolina 27599 |
Ohio State University Medical Center | Columbus, Ohio 43210 |
Sylvester Comprehensive Cancer Center | Miami, Florida |
Mt. Sinai Medical Center | New York, New York 10029 |
Christiana Care Health Services | Newark, Delaware 19713 |
Moffit Cancer Center | Tampa, Florida 33612 |
Goshen Cancer Center | Goshen, Indiana 46526 |
Herbert Werthem College of Medicine/Jackson North Medical Center | Miami, Florida 33169 |
Winship Cancer Institute/Emory University Hospital | Atlanta, Georgia 30322 |
New York Presbyterian Hospital/Weill Cornell Medical Center | New York, New York 10021 |
Thomas Jefferson University Medical Center | Philadelphia, Pennsylvania 19107 |