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Imatinib in Adult Patients With Metastatic Ocular Melanoma (O-Mel-Inib)

This study has been terminated.
(Study stopped at the end of the first step)
Sponsor:
Collaborators:
Novartis
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00421317
First received: January 9, 2007
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.


Condition Intervention Phase
Melanoma
 Drug: Imatinib
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Progression-free rate at 3 months

Secondary Outcome Measures:
  • Progression-free rate at 6 and 12 months
  • Response rate according to RECIST criteria
  • Toxicity
  • Global survival,Progression-free survival
  • Predictive genomic factors of response

Enrollment: 13
Study Start Date: December 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Imatinib
    800 mg/day until disease progression or toxicity
Detailed Description:

Further study details as provided by Centre Oscar Lambret

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic ocular melanoma
  • Age > or = 18 years old
  • Measurable metastases > or = 10 mm according to RECIST criteria
  • PS-WHO < or = 1 or IK > 70 percent
  • Normal hepatic function
  • PNN > 1500/mm3, platelets > or = 100 000/mm3
  • Contraception
  • Informed consent signed

Exclusion Criteria:

  • Patient with two prior lines of systemic treatment (chemotherapy, immunotherapy or association)
  • Other evolutive neoplasic disease
  • Severe hepatic insufficiency
  • Severe renal insufficiency
  • Somatic or psychiatric co-morbidity incompatible with the protocol
  • Leptomeningeal or cerebral metastatic dissemination
  • Pregnant or lactating woman
  • Other antitumoral treatment
  • Patient participating to another clinical trial with an experimental drug
  • Known hypersensitivity to Imatinib or one of its excipients
  • Resecable single metastasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421317

Locations
France
Centre Francois Baclesse
Caen, France, 14076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre Georges-Francois Leclerc
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
Centre Hospitalier Regional Universitaire
Lille, France, 59035
Centre Leon Berard
Lyon, France, 69373
Centre Val d'Aurelle Paul Lamarque
Montpellier, France, 34298
Institut Curie
Paris, France, 75248
Hopital Universitaire de Hautepierre
Strasbourg, France, 67098
Centre Paul Strauss
Strasbourg, France, 67065
Institut Claudius Regaud
Toulouse, France, 31052
Centre Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Oscar Lambret
Novartis
National Cancer Institute, France
Investigators
Principal Investigator: PENEL Nicolas, MD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00421317     History of Changes
Other Study ID Numbers: 2005-08
Study First Received: January 9, 2007
Last Updated: August 10, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
Ocular, Metastatic melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013