Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma

Inclusion Criteria:

• 18 years of age or older
• Histologically documented diagnosis of mucosal melanoma or acral melanoma or chronically sun damaged melanoma as evidenced by solar elastosis on pathology
• Patient's tumor with evidence for KIT mutation or amplification. Patient tumors that already have documented mutations or amplification do not have to have tissue submitted again for analysis to confirm eligibility
• Have failed, progressed, or not been able to tolerate other tyrosine kinase inhibitors including but not limited to imatinib mesylate, sunitinib or dasatinib treatment.
• At least one measurable site of disease
• ECOG Performance Status 0, 1 or 2
• Adequate organ function as outlined in the protocol
• Negative pregnancy test for female patients of childbearing potential

Exclusion Criteria:

• Patient has received any other investigational agents within 28 days of first day of study drug dosing unless the disease is rapidly progressing
• Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ
• Female patients who are pregnant or breast-feeding
• Patient has a severe and/or uncontrolled medical disease
• Patient has a rare hereditary problem of galactose intolerance, severe lactase deficiency or of glucose-galactose malabsorption
• Patient with electrolyte abnormality unless the level can be corrected to normal levels prior to initiating study drug
• Known brain metastasis
• Known chronic liver disease
• Patient has received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing (6 weeks for nitrosourea or mitomycin-C)
• Patient previously received radiotherapy to 25% or greater of the bone marrow
• Patient had a major surgery within 2 weeks prior to study entry
• Impaired cardiac function
• QTc > 450msec on screening ECG
• Myocardial infarction within one year prior to starting nilotinib
• Other clinically significant heart disease
• Patients who are currently receiving treatment with any of the medications that have the potential to prolong QT interval
• Patients who are currently receiving Warfarin > 1mg/day
• Patient with any significant history of non-compliance to medical regimens or with the inability to grant reliable informed consent
• Prior therapy with nilotinib