A Multicenter, Open-label, Single Arm Clinical Trial to Determine the Safety of ABX-EGF Extended Therapy in Subjects With Metastatic Colorectal Cancer
A Multicenter, Open-label, Single Arm Clinical Trial to Determine the Safety of ABX-EGF Extended Therapy in Subjects With Metastatic Colorectal Cancer
The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in subjects with metastatic colorectal cancer who were previously randomized to best supportive care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.
Inclusion Criteria: - Subject previously randomized to BSC in protocol 20020408 and subsequently determined to have progressive disease - ECOG performance status of 0, 1 or 2 - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Myocardial infarction in time interval between completing 20020408 and enrollment in study - History or evidence of interstitial pneumonitis or pulmonary fibrosis - Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics during the time interval between completing 20020408 protocol and enrollment in this study - Use of systemic chemotherapy or radiotherapy during the time interval between completing 20020408 protocol and enrollment in this study