Selumetinib: Phase II data

An open-label, dose-escalation, U.S. Phase I trial in 16 patients with advanced solid tumors showed that selumetinib plus cixutumumab ( IMC-A12) produced 1 partial response and 4 cases of stable disease in 10 evaluable patients. A dose-limiting toxicity (DLT) of visual changes occurred at the 75 mg selumetinib dose. Grade 3 adverse events included nausea/vomiting, visual changes/retinopathy, methicillin-resistant Staphylococcus aureus (MRSA) skin infection, hyperglycemia and stroke. The recommended Phase II dose is twice-daily 50 mg selumetinib plus twice-weekly 12 mg/kg cixutumumab. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...