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.
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
William Wegener, MD, PHD
United States: Food and Drug Administration
|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|