Overview

This trial has been completed.

Condition uveal melanoma
Treatment sorafenib at a dose of 800 mg / day
Phase phase 2
Sponsor University Hospital, Caen
Start date February 2012
End date January 2015
Trial size 32 participants
Trial identifier NCT02517736, 09-067

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
sorafenib at a dose of 800 mg / day

Primary Outcomes

Measure
non-tumor progression rate
time frame: 24 weeks after initiation of treatment

Eligibility Criteria

All participants at least 18 years old.

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by University Hospital, Caen.