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Brief Title: QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas
Study ID: NCT01231347
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR