Trial | NCT00421317  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    imatinib ...

  • Study Participants

    13
The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.
Further study details as provided by Centre Oscar Lambret
Study Started
Dec 31
2005
Primary Completion
Mar 31
2007
Study Completion
Mar 31
2007
Last Update
Jan 06
2016
Estimate

Drug Imatinib

800 mg/day until disease progression or toxicity

Criteria 

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
No Results Posted