AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
800
AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
Placebo administered intravenously on days 1 and 15 of a 28 day cycle
AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
Research Site
Fullerton, California, United States
Research Site
La Jolla, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Rancho Mirage, California, United States
Research Site
Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas
The primary endpoint of the study was OS, defined as the time from randomization to death.
Time frame: From randomization up to 20 months
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Redondo Beach, California, United States
Research Site
Santa Maria, California, United States
Research Site
Chicago, Illinois, United States
Research Site
Harvey, Illinois, United States
Research Site
Quincy, Illinois, United States
...and 142 more locations