Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
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.