Clinical trial NCT02517736: Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uveal Melanoma
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: non-tumor progression rate
timeFrame: 24 weeks after initiation of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Service d'ophtalmologie, CHU de Caen
Study officials:
References: