Volume 5, Number 10, Supplement 13 (October 2008)

Current Clinical Trials

1

Evaluating the addition of AMG 655 to mFOLFOX6/bevacizumab in metastatic colorectal cancer

Charles S. Fuchs, MD, and Leonard B. Saltz, MD

Dana-Farber Cancer Institute, Boston, MA, and Memorial Sloan-Kettering Cancer Center, New York, NY

Fluoropyrimidine-based chemotherapy has been the mainstay of treatment of advanced colorectal cancer (CRC) for over 4 decades. More recently, the addition of bevacizumab to fluorouracil-based combination chemotherapy has resulted in clinically meaningful improvement in survival in patients with metastatic disease. Still, there remains an urgent unmet need for potentially more effective treatment options. AMG 655 is an investigational fully human monoclonal agonist antibody in the early stages of development by Amgen as a potential therapy for several types of cancer. AMG 655 targets death receptor 5 (DR5), a cell-surface receptor that induces apoptosis. Amgen study 20060464 (ClinicalTrials.gov identifier NCT00625651) is a phase Ib/II study of AMG 655 in combination with modified (m) FOLFOX6 (5-fluorouracil, leucovorin, and oxaliplatin) and bevacizumab as first-line therapy of metastatic CRC. 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 mFOLFOX6/bevacizumab. The second part is a multicenter, randomized, double-blinded, placebo-controlled three-arm trial designed to evaluate the efficacy of two different AMG 655 doses in combination with mFOLFOX6/bevacizumab compared with mFOLFOX6/bevacizumab alone. This part is now actively enrolling patients. Its primary endpoint is progression-free survival.

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