A Phase II Study of Nilotinib (AMN107) 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