Imatinib in Adult Patients With Metastatic Ocular Melanoma

Melanoma Clinical Trial

— O-Mel-Inib  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00421317
• Other study ID #: O-Mel-Inib 0508
• Status: Terminated
• Phase: Phase 2
• First received: January 9, 2007
• Last updated: January 5, 2016
• Start date: December 2005
• Est. completion date: March 2007

Study information

• Verified date: January 2016
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Description:

Further study details as provided by Centre Oscar Lambret

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
France	Centre Francois Baclesse	Caen
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Georges-Francois Leclerc	Dijon
France	Centre Hospitalier Regional Universitaire	Lille
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
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

Sponsors (3)

Lead Sponsor	Collaborator
Centre Oscar Lambret	National Cancer Institute, France, Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free rate at 3 months
Secondary	Progression-free rate at 6 and 12 months
Secondary	Response rate according to RECIST criteria
Secondary	Toxicity
Secondary	Global survival,Progression-free survival
Secondary	Predictive genomic factors of response