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Ref Type Journal Article
PMID (26424760)
Authors Lee SJ, Kim TM, Kim YJ, Jang KT, Lee HJ, Lee SN, Ahn MS, Hwang IG, Lee S, Lee MH, Lee J
Title Phase II Trial of Nilotinib in Patients With Metastatic Malignant Melanoma Harboring KIT Gene Aberration: A Multicenter Trial of Korean Cancer Study Group (UN10-06).
Journal Vol Issue Date Pages Journal Short Title
The oncologist 20 11 2015 Nov 1312-9 Oncologist
URL
Abstract Text KIT has been suggested to be a potential therapeutic target for malignant melanoma. We evaluated the antitumor activity and safety of the KIT inhibitor nilotinib in metastatic melanoma patients harboring KIT gene mutations or amplifications.We conducted a phase II multicenter trial of nilotinib in metastatic malignant melanoma with KIT mutations or amplifications. Patients received 400 mg oral nilotinib twice daily. The primary endpoint was response rate, and if seven or more responders were observed from the cumulative 36 patients, nilotinib would be considered worthy of further testing in this study population.Between October 2009 and June 2013, 176 patients underwent molecular screening for KIT gene aberrations, and 42 patients harboring KIT gene mutations and/or amplification were enrolled in the study. Overall, 25 (59.5%), 15 (35.7%), and 2 (4.8%) patients had KIT mutations, KIT amplifications, and both KIT mutations and amplification, respectively. Of the 42 enrolled patients, 1 patient achieved complete response, 6 patients achieved partial response, and 17 patients achieved stable disease, resulting in an overall response rate of 16.7% (95% confidence interval [CI]: 5.4%-28.0%) and a disease control rate of 57.1% (95% CI: 42.1%-72.1%). The median duration of response was 34 weeks (range: 5-55 weeks). Of the 7 responders, 6 patients had KIT mutations (exon 11: 5 patients; exon 17: 1 patient), and 1 patient had KIT amplification only.Although this study did not meet its primary endpoint of response rate, nilotinib showed durable response in a subset of metastatic melanoma patients with specific KIT mutations.KIT aberration can be detected in a subset of metastatic melanoma patients. This phase II trial showed that nilotinib demonstrates durable response in a subset of patients with KIT mutations. The safety profile was very tolerable. This study suggests that a KIT inhibitor may benefit a small subset of metastatic melanoma patients with KIT mutations.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
KIT I817L missense unknown KIT I817L lies within the protein kinase domain of the Kit protein (UniProt.org). I817L has been identified in the scientific literature (PMID: 26424760, PMID: 29191620, PMID: 19369623), but has not been biochemically characterized and therefore, its effect on Kit protein function is unknown (PubMed, Feb 2025).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KIT exon 11 del acral lentiginous melanoma predicted - sensitive Nilotinib Case Reports/Case Series Actionable In a Phase II trial, Tasigna (nilotinib) treatment resulted in an overall response rate of 16.7% (7/42, 1 complete and 6 partial responses) and a disease control rate of 57.1% in melanoma patients harboring KIT mutations (n=25), amplification (n=15), or both (n=2), including a partial response with a duration of response of 13 weeks in a patient with acral melanoma harboring a KIT exon 11 deletion (PMID: 26424760; NCT01099514). 26424760
KIT V559A acral lentiginous melanoma predicted - sensitive Nilotinib Case Reports/Case Series Actionable In a Phase II trial, Tasigna (nilotinib) treatment resulted in an overall response rate of 16.7% (7/42, 1 complete and 6 partial responses) and a disease control rate of 57.1% in melanoma patients harboring KIT mutations (n=25), amplification (n=15), or both (n=2), including a partial response with a duration of response of 38 weeks in a patient with acral melanoma harboring KIT V559A (PMID: 26424760; NCT01099514). 26424760
KIT L576P acral lentiginous melanoma predicted - sensitive Nilotinib Case Reports/Case Series Actionable In a Phase II trial, Tasigna (nilotinib) treatment resulted in an overall response rate of 16.7% (7/42, 1 complete and 6 partial responses) and a disease control rate of 57.1% in melanoma patients harboring KIT mutations (n=25), amplification (n=15), or both (n=2), including 1 complete and 2 partial responses in patients with acral melanoma harboring KIT L576P (n=4) (PMID: 26424760; NCT01099514). 26424760
KIT exon11 melanoma sensitive Nilotinib Phase II Actionable In a Phase II trial, Tasigna (nilotinib) treatment resulted in an overall response rate of 16.7% (7/42, 1 complete and 6 partial responses) and a disease control rate of 57.1% in melanoma patients harboring KIT mutations (n=25), amplification (n=15), or both (n=2), 5 of the responders harbored KIT exon 11 mutations, 1 responder harbored an KIT exon 17 mutation, and 1 with KIT amplification (PMID: 26424760; NCT01099514). 26424760
KIT I817L acral lentiginous melanoma predicted - sensitive Nilotinib Case Reports/Case Series Actionable In a Phase II trial, Tasigna (nilotinib) treatment resulted in an overall response rate of 16.7% (7/42, 1 complete and 6 partial responses) and a disease control rate of 57.1% in melanoma patients harboring KIT mutations (n=25), amplification (n=15), or both (n=2), including a partial response with a duration of response of 55 weeks in a patient with acral melanoma harboring KIT I817L (PMID: 26424760; NCT01099514). 26424760