A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of AMG 479 or Placebo in Combination With Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the Pancreas
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled
trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for
locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects
will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo.
Randomization will be stratified by ECOG (0 or 1).
Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of
every 28 day cycle. Treatment will continue until radiographic disease progression,
unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
The primary endpoint is progression-free survival (PFS) as defined as the time from randomization to progression (per RECIST v1.1) or death.
Approximately 23 months
United Kingdom: Medicines and Healthcare Products Regulatory Agency
|Research Site||Anaheim, California|
|Research Site||Chattanooga, Tennessee|