Metastatic Melanoma With KIT Aberration Clinical Trial
Official title:
Phase II Study of Nilotinib in Metastatic Melanoma With KIT Aberrations
Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma
(Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT
mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas
(Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase
inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both
imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone
and in combination with imatinib in patients with imatinib-resistant gastrointestinal
stromal tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib
alone and 56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008,
abstr 10553).
Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT
mutations.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment