Safety of TKI258 in Advanced/Metastatic Melanoma Subjects

Inclusion criteria

• Confirmed diagnosis of locally advanced or metastatic melanoma (American Joint Committee on Cancer [AJCC] stage IIIB, IIIC or IV) that is refractory to standard therapy or for which no curative standard therapy exists.
• Measurable disease
• Must be eighteen years of age or older
• Must meet baseline laboratory requirements
• ECOG performance status 0 or 1
• Adults of reproductive potential must agree to use effective contraception or be sterile

Exclusion criteria

• Concurrent therapy with any other investigational agent
• Uncontrolled central nervous system metastases
• Impaired cardiac function or clinically significant cardiac disease
• Received

• chemotherapy, targeted therapy or monoclonal antibody therapy ≤4 weeks
• biological therapy or immunotherapy (therapeutic or diagnostic) ≤2 weeks
• an investigational agent (therapeutic or diagnostic) ≤4 weeks prior to starting study drug or has not recovered from side effects of such therapy
• Received any hematopoietic colony-stimulating factor (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin is allowed.
• Has undergone major surgery ≤ 2 weeks prior to starting study drug or has not recovered from side effects of such surgery.
• Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea, diarrhea, vomiting
• Pregnant or breast feeding women
• History of another primary malignancy that is currently clinically significant or currently requires active intervention.
• Chronic anticoagulation therapy with full strength aspirin, Coumadin, or heparin.
• History of thromboembolic or cerebrovascular events within the last 12 months.
• History of rectal bleeding, bloody vomit, or spitting up blood within the last 3 months.
• Known diagnosis of HIV infection (HIV testing is not mandatory)
• Use of ketoconazole, erythromycin, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's wort and quinidine is prohibited.
• Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study-drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, make the patient inappropriate for this study