NCT00831974已完成2 期
Phase IIa, Open-label, Randomized Study of Oral AB1010 in Patients With Systemic Indolent Mastocytosis With Handicap and Not Bearing Activating Point Mutations in the Phosphotransferase Domain of c-Kit Such as the Main Mutation Asp-816-Val (D816V)
AB Science0 个研究点目标入组 23 人开始时间: 2004年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 主要终点
- Response on: Pruritus score, Number of flush per day, Pollakyuria (on a daily basis), Number of stools per day, QLQ-C30 score, Hamilton Rating Scale for depression
研究概览
简要总结
This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in patients suffering from indolent systemic mastocytosis with handicap.
详细描述
Efficacy will be assessed based on:
Pruritus score Number of flush per day Pollakyuria (on a daily basis) Number of stools per day QLQ-C30 score Hamilton Rating Scale for depression
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented Indolent systemic mastocytosis with handicap (ISMwh) having at least 2 infiltrated* organs (skin and /or bone-marrow and/or internal organ).
- •Bone-marrow, or skin or internal biopsy-documented mastocytosis and evaluable disease.
- •The absence of an activating point mutation in the phosphotransferase domain of c-Kit such as D816V c-Kit mutation in at least one of the two infiltrated organs: bone marrow and/or skin and/or other tissue.
- •Handicap defined as at least one of the following handicaps:
- •a number of flush per day ≥ 1 ,
- •a pruritus score ≥ 9 ,
- •a number of stools per day ≥ 4 ,
- •a Pollakyuria (on a per day basis) ≥ 8 ,
- •a QLQ-C30 score ≥ 83 ,
- •a Hamilton rating scale for depression ≥ 12
排除标准
- •Performance status > 2 (ECOG).
- •Inadequate organ function, except if the abnormalities are due to involvement by mast cells
研究组 & 干预措施
2
Experimental
masitinib (AB1010) 6 mg/kg/day
干预措施: masitinib (AB1010) (Drug)
1
Experimental
masitinib (AB1010) 3 mg/kg/day
干预措施: masitinib (AB1010) (Drug)
结局指标
主要结局
Response on: Pruritus score, Number of flush per day, Pollakyuria (on a daily basis), Number of stools per day, QLQ-C30 score, Hamilton Rating Scale for depression
时间窗: 12 weeks
次要结局
- AFIRMM score, reduction of organ infiltration,level of tryptase, reduction on bio markers (TNFα, eosinophils, histamine levels), pharmacokinetic profile of AB1010(12 weeks)
研究者
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