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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)

Primary Purpose

Uveal Melanoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Sorafenib at a dose of 800 mg / day
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveal Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'ophtalmologie, CHU de Caen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sorafenib at a dose of 800 mg / day

Arm Description

Outcomes

Primary Outcome Measures

non-tumor progression rate
with sorafenib at a dose of 800 mg / day

Secondary Outcome Measures

Full Information

First Posted
August 5, 2015
Last Updated
January 31, 2017
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02517736
Brief Title
Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination
Acronym
O-Mel-Sora
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
January 13, 2015 (Actual)
Study Completion Date
January 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sorafenib at a dose of 800 mg / day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sorafenib at a dose of 800 mg / day
Primary Outcome Measure Information:
Title
non-tumor progression rate
Description
with sorafenib at a dose of 800 mg / day
Time Frame
24 weeks after initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Service d'ophtalmologie, CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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