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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02517736
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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


Condition or disease Intervention/treatment Phase
Uveal Melanoma Drug: Sorafenib at a dose of 800 mg / day Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : February 2012
Actual Primary Completion Date : January 13, 2015
Actual Study Completion Date : January 13, 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Sorafenib

Arm Intervention/treatment
Experimental: sorafenib at a dose of 800 mg / day Drug: Sorafenib at a dose of 800 mg / day



Primary Outcome Measures :
  1. non-tumor progression rate [ Time Frame: 24 weeks after initiation of treatment ]
    with sorafenib at a dose of 800 mg / day



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517736


Locations
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France
Service d'ophtalmologie, CHU de Caen
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02517736    
Other Study ID Numbers: 09-067
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action