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A Phase II Study of Nilotinib (AMN107) in Patients with Metastatic Mucosal, Acral, or Chronically Sun-Damaged Melanoma
[Protocol 09-055]
- Full Title :
- A PHASE II STUDY OF NILOTINIB (AMN107) IN TKI RESISTANT OR INTOLERANT PATIENTS WITH METASTATIC MUCOSAL, ACRAL OR CHRONICALLY SUN DAMAGED MELANOMA
- Purpose :
The purpose of this study is to evaluate the safety and effectiveness of nilotinib in patients with metastatic mucosal, acral, or chronically sun-damaged melanoma that persists despite prior treatment with a medicine that affects c-KIT function or which caused bad side effects. Nilotinib is approved for the treatment of chronic myelogenous leukemia; its use for melanoma is considered investigational.
Nilotinib is a kind of drug called a protein kinase inhibitor. It blocks a protein called c-KIT. A mutation or change in the normal c-KIT protein helps cancer cells grow and spread. It is hoped that nilotinib will block c-KIT and stop the growth of melanomas with an abnormal form of this protein.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic mucosal, acral, or chronically sun-damaged melanoma that contains an abnormal form of the c-KIT protein.
- Patients' disease must have progressed despite prior treatment with imatinib, sunitinib, or dasatinib, or patients must have been unable to tolerate these treatments.
- At least 2 weeks must have passed since major surgery and 4 weeks since prior chemotherapy and entry into the study. Patients must have recovered from any side effects.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Richard D. Carvajal at 212-639-5096.
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