EUCTR2008-000972-25-BG进行中（未招募）1 期
A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicap
AB SCIENCE0 个研究点目标入组 223 人开始时间: 2011年2月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 223
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient with one of the following documented mastocytosis as per WHO classification:
- •?Smouldering Systemic Mastocytosis
- •?Indolent Systemic Mastocytosis
- •?Cutaneous Mastocytosis
- •2.Patient with documented mastocytosis and evaluable disease based upon histological criteria: typical infiltrates of mast cells in a multifocal or diffuse pattern in skin and/or bone marrow biopsy
- •3.Patient with documented treatment failure of his/her handicap(s) with at least one of the following therapy used at optimized dose (refer to table 2):
- •?Proton pump inhibitor
- •?Osteoclast inhibitor
- •?Cromoglycate Sodium
- •?Antileukotriene
- •4.Handicapped status defined as at least two of the following handicaps, including at least one among pruritus, flushes, depression and asthenia:
- •?pruritus score = 6
- •?number of flushes per week = 7
- •?Hamilton rating scale (depression) = 10
- •?number of stools per day = 4 ,
- •?number of mictions per day = 8 ,
- •?Fatigue Impact Scale total score (asthenia) = 40
- •5.Patients with OPA > 2 (moderate to intolerable general handicap)
- •6.ECOG = 2
- •7.Patient with adequate organ function :
- •?absolute neutrophil count (ANC) = 2.0 x 109/L,
- •?platelets (PTL) = 100 x 109/L
- •?AST/ALT = 2.5x ULN (= 5 x ULN in case of liver mast cell involvement),
- •?bilirubin = 1.5x ULN
- •?creatinin clearance =50 mL/min (Cockrot and Gault formula)
- •?albumin > 0.75 x LLN
- •?urea = 1.5 x ULN
- •?proteinuria < 30mg/dL on the dipstick;; in case of proteinuria = 30 mg/dL, 24 hours proteinuria should be < 1.5g/24 hours
- •8.Male or female patient with age = 18 years
- •9.Men and women of child bearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test) must agree to use 2 methods of medically acceptable forms of contraception during the study. Men and women of childbearing potential must agree upon using contraception for three months following their participation in the study
- •10.Patient should be able and willing to comply with study visits and procedures per protocol
- •11.Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed
- •12.Patient must be covered by insurance for routine costs
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patient with one of the following mastocytosis:
- •?Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD)
- •?Mast cell leukemia (MCL)
- •?Aggressive systemic mastocytosis (ASM)
- •2.Previous treatment with any Tyrosine Kinase Inhibitor
- •3.Patient presenting with cardiac disorders defined by at least one of the following condition:
- •a.Ischemic heart disease, defined by at least one of the following condition:
- •i.Medical history of ischemic heart disease
- •ii.Clinical symptoms of ischemic heart disease
- •iii.Q wave > 3 mm on the electrocardiogram
- •iv.ST elevation or depression > 2 mm on the electrocardiogram
- •v.Negative T wave in at least 2 leads of the electrocardiogram
- •b.Cardiac failure, defined by at least one of the following condition:
- •i.Medical history of cardiac failure defined by a previous left ventricular ejection fraction = 50%
- •ii.Clinical symptoms of cardiac failure
- •iii.NT proBNP = 300 pg/mL and/or troponin T > 0.1 ng/mL
- •c.Conduction disorders or arrhythmia, defined by at least one of the following and confirmed by electrocardiogram:
- •i.Severe ventricular arrhythmia (frequent premature ventricular beats)
- •ii.Atrioventricular block at second or third level
- •iii.Left bundle branch block
- •4.Patient who had major surgery within 2 weeks prior to screening visit
- •5.Vulnerable population defined as:
- •?Life expectancy < 6 months
- •?Patient with < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ
- •?Patient with any severe and/or uncontrolled medical condition
- •?Patient with known diagnosis of human immunodeficiency virus (HIV) infection
- •6.Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
- •7.Patient with any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events
- •Previous treatment
- •8.Change in the symptomatic treatment of mastocytosis or administration of any new treatment of mastocytosis within 4 weeks prior to baseline
- •9.Treatment with any investigational agent within 4 weeks prior to baseline
研究者
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