Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

Inclusion criteria

• Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease
• Documented KIT aberration
• Adequate organ function as defined by the following criteria:

• Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
• Total serum bilirubin ≤ 1.5 x ULN
• Absolute neutrophil count (ANC) ≥ 1500/µL
• Platelets ≥ 100,000/µL
• Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated)
• Serum calcium ≤ 12.0 mg/dL
• Serum creatinine ≤ 1.5 x ULN
• Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
• May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2, chemotherapy
• At least one measurable lesion by RECIST criteria
• ECOG PS 0-2

Exclusion criteria

• Major surgery or radiation therapy within 4 weeks of starting the study treatment.
• History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
• Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
• QTc > 470 msec on baseline EKG.
• Pregnancy or breastfeeding.