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Investigational New Drugs

, Volume 26, Issue 6, pp 561–565 | Cite as

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

  • Nicolas PenelEmail author
  • Corinne Delcambre
  • Xavier Durando
  • Stéphanie Clisant
  • Mohamed Hebbar
  • Sylvie Negrier
  • Charles Fournier
  • Nicolas Isambert
  • Frédéric Mascarelli
  • Frédéric Mouriaux
PHASE II STUDIES

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.

Keywords

Uveal melanoma Imatinib mesylate Metastasis Phase II Targeted therapy 

Notes

Acknowledgment

The authors would like to thank Yvette Vendel, Muriel Chapoutier and Elodie Desrennes. This study was supported by Clinical Research grant RC-071-2005 from Institut National du Cancer (Cancéro-pôle Nord-Ouest) and grant from Novartis Pharmaceutical (to NP).

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Copyright information

© Springer Science+Business Media, LLC 2008

Authors and Affiliations

  • Nicolas Penel
    • 1
    • 2
    Email author
  • Corinne Delcambre
    • 3
  • Xavier Durando
    • 4
  • Stéphanie Clisant
    • 5
  • Mohamed Hebbar
    • 6
  • Sylvie Negrier
    • 7
  • Charles Fournier
    • 8
  • Nicolas Isambert
    • 9
  • Frédéric Mascarelli
    • 10
  • Frédéric Mouriaux
    • 10
    • 11
  1. 1.Département de Cancérologie GénéraleCentre Oscar LambretLilleFrance
  2. 2.Equipe d’Accueil 2694: Santé Publique, Epidémiologie et modélisation des maladies chroniquesUniversité Lille IILilleFrance
  3. 3.Service d’Oncologie MédicaleCentre François BaclesseCaenFrance
  4. 4.Service d’Oncologie MédicaleCentre Jean PerrinClermont-FerrandFrance
  5. 5.Unité Intégrée de Recherche CliniqueCentre Oscar LambretLilleFrance
  6. 6.Service Universitaire d’Oncologie MédicaleCHRULilleFrance
  7. 7.Service d’Oncologie MédicaleCentre Léon BérardLyonFrance
  8. 8.Unité de BiostatistiquesCentre Oscar LambretLilleFrance
  9. 9.Service d’Oncologie MédicaleCentre Georges-François LeclercDijonFrance
  10. 10.Centre de Recherche des Cordeliers, UMR S 872 et INSERM U 872Université Pierre et Marie Curie et Université Paris DescartesParisFrance
  11. 11.Service Universitaire d’OphtalmologieCHRUCaenFrance

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