Imatinib in Adult Patients With Metastatic Ocular Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-03-31

Brief Summary

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

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Detailed Description

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Further study details as provided by Centre Oscar Lambret

Conditions

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Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Imatinib

800 mg/day until disease progression or toxicity

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No