Cancer Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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