Study Stopped
Study stopped at the end of the first step
Imatinib in Adult Patients With Metastatic Ocular Melanoma
O-Mel-Inib
A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma
1 other identifier
interventional
13
1 country
12
Brief Summary
The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2005
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 9, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2009
CompletedMarch 13, 2026
March 1, 2026
4 years
January 9, 2007
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free rate at 3 months
Secondary Outcomes (5)
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
Interventions
800 mg/day until disease progression or toxicity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- Novartiscollaborator
- National Cancer Institute, Francecollaborator
Study Sites (12)
Centre Francois Baclesse
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Georges-Francois Leclerc
Dijon, 21079, France
Centre Oscar Lambret
Lille, 59020, France
Centre Hospitalier Regional Universitaire
Lille, 59035, France
Centre Leon Berard
Lyon, 69373, France
Centre Val d'Aurelle Paul Lamarque
Montpellier, 34298, France
Institut Curie
Paris, 75248, France
Centre Paul Strauss
Strasbourg, 67065, France
Hopital Universitaire de Hautepierre
Strasbourg, 67098, France
Institut Claudius Regaud
Toulouse, 31052, France
Centre Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PENEL Nicolas, MD
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2007
First Posted
January 11, 2007
Study Start
December 1, 2005
Primary Completion
November 15, 2009
Study Completion
November 15, 2009
Last Updated
March 13, 2026
Record last verified: 2026-03