Imatinib in Adult Patients With Metastatic Ocular Melanoma

Phase 2

Terminated

• Conditions: Melanoma

• Registration Number: NCT00421317
• Lead Sponsor: Centre Oscar Lambret

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

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-01-09
• Study First Submitted QC: 2007-01-09
• Study First Posted: 2007-01-11
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-free rate at 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (12)

Centre Georges-Francois Leclerc; 🇫🇷 Dijon, France

Centre Francois Baclesse; 🇫🇷 Caen, France

Centre Hospitalier Regional Universitaire; 🇫🇷 Lille, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Val d'Aurelle Paul Lamarque; 🇫🇷 Montpellier, France

Institut Curie; 🇫🇷 Paris, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Hopital Universitaire de Hautepierre; 🇫🇷 Strasbourg, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Centre Gustave Roussy; 🇫🇷 Villejuif, France