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

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 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

, , 

Location Countries

France

Location Countries

France

NCT ID

NCT02517736

Organization ID

09-067

Responsible Party

Sponsor

Study Sponsor

University Hospital, Caen

Study Sponsor

, , 

Verification Date

January 2017