This study is part of a series of single agent and combination studies of the vascular endothelial growth factor (VEGF) trap in a variety of cancer types. Regeneron and Sanofi-Aventis are collaborating in the development and commercialization of the VEGF trap in oncology.
The multicenter study will assess the safety, tolerability and pharmacokinetics of escalating doses of the VEGF trap delivered intravenously. The study will include patients with solid malignancies that are metastatic or unresectable, and for which FOLFOX4 treatment is appropriate, such as metastatic colorectal cancer.
In addition to safety and tolerability, the investigators will measure objective response rate, duration of response, and time to tumor progression.
The VEGF trap is a fully humanized soluble VEGF receptor fusion protein with a unique mechanism of action. It is a potent angiogenesis inhibitor, binding VEGF-A more tightly than monoclonal antibodies.