EUCTR2008-000972-25-GR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 3 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 150 人开始时间: 2014年7月1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
- 150
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
- •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 fatigue:
- •- Pruritus score = 9
- •- Number of flushes per week = 8
- •- Hamilton rating scale for depression(HAMD-17) score = 19
- •- Number of stools per day = 4
- •- Number of micturition per day = 8
- •- Fatigue Impact Scale total score (asthenia) = 75
- •5. Patients with OPA > 2 (moderate to intolerable general handicap)
- •6. ECOG = 2
- •7. Patient with adequate organ function :
- •- Absolute neutrophils count (ANC) = 2.0 x 109/L,
- •- Haemoglobin = 10 g/dL
- •- Platelets (PTL) = 100 x 109/L
- •- AST/ALT = 3x ULN (= 5 x ULN in case of liver mast cell involvement),
- •- Bilirubin = 1.5x ULN
- •- Creatinine clearance >60mL/min (Cockcroft and Gault formula)
- •- Albumin >1 x LLN
- •- Proteinuria < 30mg/dL on the dipstick; in case of proteinuria = 1+ on dipstick, 24 hours proteinuria should be <1.5g/24 hours
- •8. Male or female patient aged 18 to 75 years, weight > 50 kg, BMI between 18 and 35 kg/m²
- •9. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
- •10. Male patients must use medically acceptable methods of contraception if your female partner is pregnant, from the time of the first administration of the study drug until three months following administration of the last dose of study drug.
- •Male patients must use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
- •11. Patient must be able and willing to comply with study visits and procedures per protocol
- •12. Patient must understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed
- •13. Patient must understand the patient card and follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity during the first 2 months of treatment
- •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:
- •- Cutaneous Mastocytosis
- •- Not documented Smouldering Systemic Mastocytosis or Indolent Systemic Mastocytosis
- •- Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD)
- •- Mast cell leukaemia (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 conditions:
- •- Patient with recent cardiac history (within 6 months) of:
- •- Acute coronary syndrome
- •- Acute heart failure (class III or IV of the NYHA classification)
- •- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
- •- Patient with cardiac failure class III or IV of the NYHA classification
- •- Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- •- Syncope without known aetiology within 3 months
- •- Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
- •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, or institutionalized by court decision
- •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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