Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patient… (NCT02517736) | Clinical Trial Compass
CompletedPhase 2
Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination
France32 participantsStarted 2012-02
Plain-language summary
The objective of the study is to determine the efficacy and toxicity of sorafenib in metastatic uveal melanoma.
The main objective is to determine the non-tumor progression rate 24 weeks after initiation of treatment with sorafenib at a dose of 800 mg / day
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female over 18 years old suffering from uveal melanoma with metastasis
* At least one measurable metastases by more than 10 mm acoording to Response Evaluation Criteria in Solid Tumors (RECIST)
* At least 28 days from the previous treatment (systemic or major surgery)
* Performance Index (WHO ≤ 2 or ≥ 70% Karnofsky)
* Weight loss compared to pre morbid weight \<20% in the last 12 months
* White blood cells at least 3000 / mm 3, polynuclear neutrophils less than 1500 / mm3, platelets at least 100,000 / mm3, hemoglobin at least 9.0 g / dl
* Total Bilirubin ≤1.5 x upper limit of normal (ULN) (or less than or equal to 2.5 in liver metastasis), ASAT and ALAT ≤ 2.5 x ULN (or ≤ 5 in liver metastasis) Serum Creatinine (calculated using the cockcroft-Gault method) ≤ 1.5 x ULN, Amylase and lipase \<1.5 x ULN
* prothrombin rate and international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. Possibility of using low molecular weight heparin in place of anti vitamin K treatment
* higher life expectancy than or equal to 3 months
* Negative pregnancy test for women of childbearing age and using a method of contraception during treatment
* No one benefiting from a Social Security scheme
* Informed consent and signed by the patient or his legal representative
Exclusion Criteria:
* • Patient who received more than 2 lines of treatment (chemotherapy or immunotherapy), whatever the indication
* Major surgery (excluding the…