Brief Title
Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination
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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
non-tumor progression rate
Condition
Uveal Melanoma
Intervention
Sorafenib at a dose of 800 mg / day
Study Arms / Comparison Groups
sorafenib at a dose of 800 mg / day
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
32
Start Date
February 2012
Completion Date
January 13, 2015
Primary Completion Date
January 13, 2015
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02517736
Organization ID
09-067
Responsible Party
Sponsor
Study Sponsor
University Hospital, Caen
Study Sponsor
, ,
Verification Date
January 2017