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

Uveal Melanoma Clinical Trial

— O-Mel-Sora  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517736
• Other study ID #: 09-067
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2015
• Last updated: January 31, 2017
• Start date: February 2012
• Est. completion date: January 13, 2015

Study information

• Verified date: January 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 13, 2015
• Est. primary completion date: January 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Service d'ophtalmologie, CHU de Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non-tumor progression rate	with sorafenib at a dose of 800 mg / day	24 weeks after initiation of treatment