Medline ® Abstract for Reference 48
of 'Molecularly targeted therapy for metastatic melanoma'
O-Mel-Inib: a Cancéro-pôle Nord-Ouest multicenter phase II trial of high-dose imatinib mesylate in metastatic uveal melanoma.
Penel N, Delcambre C, Durando X, Clisant S, Hebbar M, Negrier S, Fournier C, Isambert N, Mascarelli F, Mouriaux F
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.
Département de Cancérologie Générale, Centre Oscar Lambret, 59020, Lille, France. firstname.lastname@example.org