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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Novartis |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00788775 |
The purpose of this research study is to evaluate how effective nilotinib is in treating acral, mucosal, or melanoma arising from sun damaged skin which has spread and was not found to respond to prior treatment with Gleevec or that Gleevec was not tolerated.
Condition | Intervention | Phase |
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Mucosal Melanoma Acral Melanoma Melanoma |
Drug: Nilotinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase II Study of Nilotinib (AMN107) In Imatinib Resistant or Intolerant Patients With Metastatic Mucosal, Acral or Chronically Sun Damaged Melanoma |
Estimated Enrollment: | 25 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: F. Stephen Hodi, MD | 617-632-5053 |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | F. Stephen Hodi, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( F. Stephen Hodi, MD ) |
Study ID Numbers: | 08-244, DUS11T |
Study First Received: | November 10, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00788775 |
Health Authority: | United States: Institutional Review Board |
nilotinib |
Imatinib Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |