Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination (O-Mel-Sora)

Caen University Hospital

Status and phase: Completed; Phase 2

Conditions: Uveal Melanoma

Treatments: Drug: Sorafenib at a dose of 800 mg / day

Study type: Interventional

Funder types: Other

Identifiers

NCT02517736

09-067

Details and patient eligibility

About

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

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

sorafenib at a dose of 800 mg / day

Experimental group

Treatment:

Drug: Sorafenib at a dose of 800 mg / day