A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck

Exclusion Criteria

• •Nasopharyngeal cancer
• •Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members
• •This includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and lapatinib
• •Prior treatment with an EGFR inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed \>/=1 year before study enrollment
• •Leptomeningeal disease as the only manifestation of the current malignancy
• •Active infection requiring iv antibiotics
• •Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
• •Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures)
• •History of heart failure or serious cardiac arrhythmia
• •History of myocardial infarction within 6 months of Cycle 1, Day 1
• •Clinically significant liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, or current alcohol abuse
• •HIV infection
• •Primary central nervous system (CNS) malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
• •Pregnant or lactating women
• •Malignancies other than SCCHN within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix