A Phase II Study of the Safety and Efficacy of E7820 Plus Cetuximab in Colorectal Cancer, Preceded by a Run-in Study in Advanced Solid Tumors

Exclusion Criteria

• •Patients who have a history of previous Grade 2 or higher hypersensitivity to sulfonamide derivatives.
• •Patients previously treated with cetuximab, or who have received prior treatment with any EGFR-related cancer therapy, either an approved or investigational agent.
• •Patients with known sensitivity to murine monoclonal antibodies.
• •Patients who have had radiation to \>= 25% of their bone marrow (e.g., pelvic radiation) within 4 weeks prior to E7820 treatment.
• •Patients who have not recovered from any clinically significant (Grade 3 or 4) chemotherapy, immunotherapy, or radiotherapy related toxicity at study entry (excluding neuropathy, infertility, or alopecia).
• •Patients who have received investigational drugs or any other anti-neoplastic therapy within 28 days of E7820 treatment.
• •Patients who have had major surgery within 4 weeks of study drug administration.
• •Women who are pregnant or breast-feeding. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
• •Fertile men and fertile women who are not willing to use contraception or fertile men or fertile women with a partner who is not willing to use contraception.
• •Patients who have a positive history of human immunodeficiency virus, hepatitis B or active hepatitis C.
• •Patients with severe uncontrolled intercurrent illness/infection (excluding malignancies).
• •Patients with a history of unstable ischemic cardiac disease or more than Class II NYHA heart failure.
• •Patients with a history of clinically significant arterial thrombosis or who have taken therapeutic doses of anticoagulants within the last 7 days.
• •Patients who have pulmonary disease that puts them at risk of hemoptysis or bleeding diathesis. Head and neck cancer patients at risk for major vessel bleeding.
• •Patients receiving therapeutics doses of anticoagulants.
• •Patients with poorly controlled type I insulin-dependent diabetes or poorly-controlled type II insulin-dependent diabetes or a fasting blood glucose \>10 mmol/L (200 mg/dL).
• •Patients with significant comorbid disease or condition, which in the Investigator's opinion would exclude the patient from the study.