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

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ClinicalTrials.gov Identifier: NCT00421317
Recruitment Status : Terminated (Study stopped at the end of the first step)
First Posted : January 11, 2007
Last Update Posted : January 6, 2016
Sponsor:
Collaborators:
Novartis
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret

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

Condition or disease Intervention/treatment Phase
Melanoma Drug: Imatinib Phase 2

Detailed Description:
Further study details as provided by Centre Oscar Lambret

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2005
Primary Completion Date : March 2007
Study Completion Date : March 2007



Intervention Details:
    Drug: Imatinib
    800 mg/day until disease progression or toxicity


Primary Outcome Measures :
  1. Progression-free rate at 3 months

Secondary Outcome Measures :
  1. Progression-free rate at 6 and 12 months
  2. Response rate according to RECIST criteria
  3. Toxicity
  4. Global survival,Progression-free survival
  5. Predictive genomic factors of response


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Centre Paul Strauss
Strasbourg, France, 67065
Hopital Universitaire de Hautepierre
Strasbourg, France, 67098
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

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00421317     History of Changes
Other Study ID Numbers: O-Mel-Inib 0508
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016

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 Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action