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

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 Overview

• Status: Completed
• Conditions: Uveal Melanoma
• Intervention / Treatment: Drug: Sorafenib at a dose of 800 mg / day

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Service d'ophtalmologie, CHU de Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sorafenib at a dose of 800 mg / day	Drug: Sorafenib at a dose of 800 mg / day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-tumor progression rate	with sorafenib at a dose of 800 mg / day	24 weeks after initiation of treatment

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): January 13, 2015
• Study Completion (Actual): January 13, 2015

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: 09-067