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Phase II Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

Phase 2
18 Years
Open (Enrolling)
Metastatic Melanoma With KIT Aberration

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Trial Information

Phase II Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

Inclusion Criteria:

1. Histologically or cytologically proven melanoma with stage IV or unresectable stage
III disease

2. Documented KIT aberration

3. 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

4. Patients with CNS metastasis must have stable neurologic function without evidence of
CNS progression within 8 weeks

5. May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2,

6. At least one measurable lesion by RECIST criteria

7. ECOG PS 0-2

Exclusion Criteria:

1. Major surgery or radiation therapy within 4 weeks of starting the study treatment.

2. History of or known carcinomatous meningitis, or evidence of symptomatic
leptomeningeal disease on screening CT or MRI scan.

3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.

4. QTc > 470 msec on baseline EKG.

5. Pregnancy or breastfeeding.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Time Frame:

1~2 year

Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

June 2013

Related Keywords:

  • Metastatic Melanoma With KIT Aberration
  • Melanoma