Status:
TERMINATED
Imatinib in Adult Patients With Metastatic Ocular Melanoma
Lead Sponsor:
Centre Oscar Lambret
Collaborating Sponsors:
Novartis
National Cancer Institute, France
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.
Detailed Description
Further study details as provided by Centre Oscar Lambret
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00421317
Start Date
December 1 2005
End Date
March 1 2007
Last Update
January 6 2016
Active Locations (12)
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1
Centre Francois Baclesse
Caen, France, 14076
2
Centre Jean Perrin
Clermont-Ferrand, France, 63011
3
Centre Georges-Francois Leclerc
Dijon, France, 21079
4
Centre Oscar Lambret
Lille, France, 59020