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A Phase II Study of Nilotinib (AMN107) In TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral or Chronically Sun Damaged Melanoma

Phase 2
18 Years
Open (Enrolling)
Mucosal Melanoma, Acral Melanoma, Melanoma

Thank you

Trial Information

A Phase II Study of Nilotinib (AMN107) In TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral or Chronically Sun Damaged Melanoma

- Participants will be given nilotinib pills. Each pill contains 200 mg of nilotinib and
participants will take two pills twice a day.

- Participants will have a physical exam weekly for the first month and then about every
other month. At every visit blood work will be performed. An EKG will be done prior to
the first dose of study medication and within 30 minutes after the first dose and also
on day 8 of month 1, 3, 6, and 9. An echocardiogram will be performed during the 3rd

- After a month of receiving the study drug participants will undergo a PET scan to see
if the drug has caused any detectable early changes in their cancer. A chest, abdomen
and pelvic CT scan will be performed at the end of month 2 and about every 8 weeks
after that to assess if the study drug is having any effect on the disease.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the proportion of this patient population who are alive and without disease progression four months after beginning treatment with nilotinib.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

F. Stephen Hodi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Mucosal Melanoma
  • Acral Melanoma
  • Melanoma
  • nilotinib
  • Melanoma



Memorial Sloan Kettering Cancer Center New York, New York  10021
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Colorado Denver, Colorado  80217
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of Chicago Chicago, Illinois  60637
Moffitt Cancer Center Tampa, Florida  33612
The Angeles Clinic and Research Institute Los Angeles, California  90025