search
Back to results

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

Primary Purpose

Melanoma

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Imatinib
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Ocular, Metastatic melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Francois Baclesse
  • Centre Jean Perrin
  • Centre Georges-Francois Leclerc
  • Centre Oscar Lambret
  • Centre Hospitalier Regional Universitaire
  • Centre Leon Berard
  • Centre Val d'Aurelle Paul Lamarque
  • Institut Curie
  • Centre Paul Strauss
  • Hopital Universitaire de Hautepierre
  • Institut Claudius Regaud
  • Centre Gustave Roussy

Outcomes

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

Full Information

First Posted
January 9, 2007
Last Updated
January 5, 2016
Sponsor
Centre Oscar Lambret
Collaborators
Novartis, National Cancer Institute, France
search

1. Study Identification

Unique Protocol Identification Number
NCT00421317
Brief Title
Imatinib in Adult Patients With Metastatic Ocular Melanoma
Acronym
O-Mel-Inib
Official Title
A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Study stopped at the end of the first step
Study Start Date
December 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Novartis, National Cancer Institute, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.
Detailed Description
Further study details as provided by Centre Oscar Lambret

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Ocular, Metastatic melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Imatinib
Intervention Description
800 mg/day until disease progression or toxicity
Primary Outcome Measure Information:
Title
Progression-free rate at 3 months
Secondary Outcome Measure Information:
Title
Progression-free rate at 6 and 12 months
Title
Response rate according to RECIST criteria
Title
Toxicity
Title
Global survival,Progression-free survival
Title
Predictive genomic factors of response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PENEL Nicolas, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospitalier Regional Universitaire
City
Lille
ZIP/Postal Code
59035
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Val d'Aurelle Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Hopital Universitaire de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

Imatinib in Adult Patients With Metastatic Ocular Melanoma

We'll reach out to this number within 24 hrs