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

Centre Oscar Lambret

Status and phase: Terminated; Phase 2

Conditions: Melanoma

Treatments: Drug: Imatinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00421317

O-Mel-Inib 0508

Details and patient eligibility

About

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

Full description

Further study details as provided by Centre Oscar Lambret

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)