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Investigational New Drugs
Published in: Investigational New Drugs 6/2008

01-12-2008 | PHASE II STUDIES

O-Mel-Inib: A Cancéro-pôle Nord-Ouest multicenter phase II trial of high-dose Imatinib mesylate in metastatic uveal melanoma

Authors: Nicolas Penel, Corinne Delcambre, Xavier Durando, Stéphanie Clisant, Mohamed Hebbar, Sylvie Negrier, Charles Fournier, Nicolas Isambert, Frédéric Mascarelli, Frédéric Mouriaux

Published in: Investigational New Drugs | Issue 6/2008

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Summary

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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Metadata
Title
O-Mel-Inib: A Cancéro-pôle Nord-Ouest multicenter phase II trial of high-dose Imatinib mesylate in metastatic uveal melanoma
Authors
Nicolas Penel
Corinne Delcambre
Xavier Durando
Stéphanie Clisant
Mohamed Hebbar
Sylvie Negrier
Charles Fournier
Nicolas Isambert
Frédéric Mascarelli
Frédéric Mouriaux
Publication date
01-12-2008
Publisher
Springer US
Published in
Investigational New Drugs / Issue 6/2008
Print ISSN: 0167-6997
Electronic ISSN: 1573-0646
DOI
https://doi.org/10.1007/s10637-008-9143-2

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