Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma
NCT00788775 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2018-11-15
Summary
Given the poor prognosis and limited treatment options available for patients with mucosal or acral/lentiginous melanomas who develop metastatic disease, genetic discoveries of KIT mutations in these cancers present the need to test multi-targeted kinase inhibitors with potent KIT inhibitory activity in this patient population. Imatinib and other tyrosine kinase inhibitors (TKIs) have the potential to be effective in this patient population, but patients may develop resistance to treatment. Therefore, in this study, we propose to test nilotinib in patients with metastatic mucosal, acral, or chronically sun-damaged melanoma following treatment with another TKI.
Conditions
- Mucosal Lentiginous Melanoma
- Acral Melanoma
- Melanoma
Interventions
- DRUG
-
Nilotinib
Sponsors & Collaborators
-
Brigham and Women's Hospital
collaborator OTHER -
Beth Israel Deaconess Medical Center
collaborator OTHER -
Massachusetts General Hospital
collaborator OTHER - collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
F. Stephen Hodi, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-23
- Primary Completion
- 2011-04-30
- Completion
- 2014-03-31
Countries
- United States
Study Locations
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