EUCTR2008-000280-42-FR进行中（未招募）1 期
A single arm, Phase II, Open-label Study to determine the efficacy of 100 mg twice daily oral dosing of midostaurin administered to patients with Agressive Systemic Mastocytosis or Mast Cell Leukemia +/- an associated hematological clonal non-mast cell lineage disease - CPKC412D2201
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •- Age > 18 and = 70 yearsof age
- •- ECOG performance status of 0-3
- •- life expectancy > 12 weeks
- •- ECG QTc interval < 450 ms
- •-meeting following lab values:
- •AST and ALT = 2.5 x ULN, if caused by ASM/MCL: =5 x ULN
- •Serum Bilirubin =1.5 ULN, if related to ASM(MCL: =3x ULN
- •Serum Creatinine = 2.0 mg/dl
- •- diagnose of ASM or MCL according to WHO criteria for SM plus the established
- •criteria for ASM or MCL
- •- informed consent
- •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
- •- patients unwilling or unable to comply with theprotocol
- •- any other concurrent severe known disease and/or severe uncontrolled medical
- •condiction which could compromise participation in teh study
- •- confirmed diagnosis of HIV infection or active viral hepatitis
- •- female patients who are pregnant or breast feeding or adults of reproductive
- •potential not employing an effective method of birth control
- •- patients who have demonstrated relapse to more than 2 prior regimen of SM
研究者
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