Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the PancreasGAMMA
Study Details
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.
Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously.
The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.
Protocol Summary
To determine if AMG 479 in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas
Timeframe: After 825 subjects randomized + 24 months
Progression free survival
Timeframe: After 825 subjects randomized + 24 months
Objective response rate
Timeframe: After 825 subjects randomized + 24 months
Time to disease progression
Timeframe: After 825 subjects randomized + 24 months
Disease control rate
Timeframe: After 825 subjects randomized + 24 months
Number of subjects with adverse events
Timeframe: After 825 subjects randomized + 24 months