A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Melanoma
Both
Melanoma
Trial Information
A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma
Further study details as provided by Centre Oscar Lambret
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free rate at 3 months
Principal Investigator
PENEL Nicolas, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Oscar Lambret
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2005-08
NCT ID:
NCT00421317
Start Date:
December 2005
Completion Date:
March 2007
Related Keywords:
- Melanoma
- Ocular, Metastatic melanoma
- Melanoma
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