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

January 5, 2016 updated by: Centre Oscar Lambret

A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Further study details as provided by Centre Oscar Lambret

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14076
        • Centre François Baclesse
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Dijon, France, 21079
        • Centre Georges-François Leclerc
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59035
        • Centre hospitalier régional universitaire
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Montpellier, France, 34298
        • Centre Val d'Aurelle Paul Lamarque
      • Paris, France, 75248
        • Institut Curie
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Strasbourg, France, 67098
        • Hopital Universitaire de Hautepierre
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Villejuif, France, 94805
        • Centre Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free rate at 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

Novartis
National Cancer Institute, France

Investigators

  • Principal Investigator: PENEL Nicolas, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

January 9, 2007

First Submitted That Met QC Criteria

January 9, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O-Mel-Inib 0508

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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