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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the proportion of this patient population who are alive and without disease progression four months after beginning treatment with nilotinib.
F. Stephen Hodi, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|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|