Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination
This trial is active, not recruiting.
|Treatment||sorafenib at a dose of 800 mg / day|
|Sponsor||University Hospital, Caen|
|Start date||February 2012|
|End date||February 2016|
|Trial size||32 participants|
|Trial identifier||NCT02517736, 09-067|
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
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
non-tumor progression rate
time frame: 24 weeks after initiation of treatment
Male or female participants at least 18 years old.
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 possible diagnostic biopsy) or radiation therapy in the 4 weeks preceding the inclusion - single liver metastasis treatable by surgery - active peptic ulcer, uncontrolled - Other progressive malignancy or during treatment (except basal cell carcinoma) - Cardiac arrhythmias requiring anti-arrhythmic (excluding beta-blockers or digoxin for chronic atrial fibrillation), active or ischemic coronary disease (myocardial infarction within the last 6 months), or heart failure> New York Heart Association (NYHA) class II - Bacterial or fungal infection active (grade> 2 Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03) - known HIV infection or chronic hepatitis B or C - cerebral or meningeal tumor metastasis (symptomatic or asymptomatic) - epileptic disease requiring anti-epileptic taken - Previous history of organ transplantation or peripheral stem cells - Patient kidney dialysis - Concomitant treatment with cytochrome P450 3A4 (CYP3A4) inducers such as rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone - Prior therapy with bevacizumab or other targeted therapy - Known or suspected allergy to sorafenib - Any unstable chronic illness can jeopardize patient safety or its compliance - Women pregnant or lactating - coagulopathy - Uncontrolled hypertension - Inability to swallow - Failure to submit to medical monitoring of the trial due to geographical, social or psychic - Persons deprived of liberty or under supervision - Patient refusing ambulatory care - Patient simultaneously participating in another clinical trial
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