NCT00788775

Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary \* To estimate the proportion of patients, with metastatic mucosal, acral, or chronically sun damaged melanomas, whose tumors have KIT aberrations, and who progressed or could not tolerate a KIT targeting tyrosine kinase inhibitor (TKI) (e.g. including but not limited to imatinib mesylate, sunitinib, or dasatanib), who are alive and without progression of disease four months after beginning treatment with nilotinib. Secondary * To determine early evidence of biologic and clinical activity by best overall response rate. * To estimate time to progression of disease and overall survival. * To determine the tolerability of nilotinib. * To evaluate the use of FDG-PET scanning in determining early biologic response to therapy. * To correlate c-kit mutational status and amplification status with response to therapy. * To evaluate the feasibility of nilotinib. * To evaluate the tolerability of nilotinib in patients with brain metastases.

Conditions

• Mucosal Lentiginous Melanoma
• Acral Melanoma
• Melanoma

Interventions

Type	Name	Description
DRUG	Nilotinib

Timeline

• Start date: 2009-01-23
• Primary completion: 2011-04-01
• Completion: 2014-03-01
• First posted: 2008-11-11
• Last updated: 2018-11-15
• Results posted: 2016-12-08

Locations

8 sites across 1 country: United States