Melanoma
Conditions
Keywords
Ocular, Metastatic melanoma
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
Interventions
DRUGImatinib
800 mg/day until disease progression or toxicity
Sponsors
Centre Oscar Lambret
Novartis
National Cancer Institute, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free rate at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free rate at 6 and 12 months | — |
| Response rate according to RECIST criteria | — |
| Toxicity | — |
| Global survival,Progression-free survival | — |
| Predictive genomic factors of response | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPENEL Nicolas, MD
Centre Oscar Lambret
Outcome results
None listed