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

NCT ID: NCT02517736

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-01-13

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

Conditions

Uveal Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sorafenib at a dose of 800 mg / day

Group Type: EXPERIMENTAL

Sorafenib at a dose of 800 mg / day

Intervention Type: DRUG

Interventions

Sorafenib at a dose of 800 mg / day

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service d'ophtalmologie, CHU de Caen

Caen, , France

Countries

France

Other Identifiers

09-067

Identifier Type: -

Identifier Source: org_study_id