Volume 5, Number 11, Supplement 17 (November 2008)

Current Clinical Trials

1

A phase Ib/II study of AMG 655 or AMG 479 in combination with gemcitabine for metastatic pancreatic cancer

Hedy Lee Kindler, MD

University of Chicago Medical Center, Chicago, IL

Pancreatic cancer is the fourth leading cause of cancer death in the United States and has the worst outcome of any solid tumor. Since current treatments produce only modest improvements in survival, novel approaches are clearly needed. This multicenter phase Ib/II trial combines gemcitabine with one of two investigational monoclonal antibodies (AMG 655 or AMG 479) or placebo. AMG 655 is a fully human monoclonal agonist antibody that targets the extracellular domain of human death receptor 5 (DR5). AMG 479 is a fully human monoclonal antibody directed against type 1 insulin-like growth factor receptor (IGF-1R). Both products are in early-stage development by Amgen for the treatment of various cancers. The first part of this trial, already completed, is an open-label dose-escalation study designed to determine the safety, tolerability, and maximum tolerated dose of AMG 655 when combined with gemcitabine. The randomized phase II portion (part 2) will determine in patients with previously untreated metastatic pancreatic cancer the efficacy, as assessed by the 6-month survival rate, and safety of AMG 655, AMG 479, or placebo when given with standard-dose (1,000 mg/m²) gemcitabine. This portion of the study is now actively enrolling patients; approximately 120 will be recruited.

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