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Medline ® Abstract for Reference 48

of 'Molecularly targeted therapy for metastatic melanoma'

48
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O-Mel-Inib: a Cancéro-pôle Nord-Ouest multicenter phase II trial of high-dose imatinib mesylate in metastatic uveal melanoma.
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Penel N, Delcambre C, Durando X, Clisant S, Hebbar M, Negrier S, Fournier C, Isambert N, Mascarelli F, Mouriaux F
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Invest New Drugs. 2008;26(6):561. Epub 2008 Jun 13.
 
BACKGROUND: Nowadays, there is no consensual and effective treatment in metastatic uveal melanoma (MUM). Numerous preclinical data (for example, 75% of MUM express c-kit) suggest that imatinib mesylate (IM) may be a potential treatment of UMM.
METHODS: The primary objective of this phase II trial was to determine the non-progression rate at 3 months for patients receiving IM at dose of 400 mg twice per day orally. The study was based on a Simon's optimal design, which allows entry a total of 29 patients, if at least two non-progressions among ten first patients were observed.
RESULT: Thirteen patients including ten assessable patients were enrolled in 12 months. No objective response and only one stable disease with duration of 5 months were noted. Five and one out of 13 enrolled patients experienced grade 3 and grade 4 toxicities, respectively. The most common severe adverse events were abdominal pain. The overall survival was 10.8 months.
CONCLUSIONS: Despite promising preclinical data, IM is an inactive single agent in MUM. This phase II clinical trial has been stopped at the first step.
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Département de Cancérologie Générale, Centre Oscar Lambret, 59020, Lille, France. n-penel@o-lambret.fr
PMID