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