EUCTR2008-000280-42-NL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 ofmidostaurin administered to patients with Agressive Systemic Mastocytosis or Mast Cell Leukemia +/- anassociated 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
- 116
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
- •- Male or female pts aged = 18 years of age
- •- ECOG performance status of 0-3
- •- life expectancy > 12 weeks
- •- ECG QTc interval = 450 ms
- •- 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
- •- diagnosed with ASM or MCL according to WHO criteria for SM plus for ASM or MCL
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
排除标准
- •- Patients unwilling or unable to comply with the protocol
- •- Any other concurrent severe known disease and/or severe uncontrolled medical
- •condiction which could compromise participation in the study
- •- Patients with cardiovascular disease including congestive heart failure grade III or IV according to the NYHA classification, left ventricular ejection fraction of <50%, myocardial infection within previous 6 months and poorly controlled hypertension
- •- Confirmed diagnosis of HIV infection or active viral hepatitis
- •- Female patients who are pregnant or breast feeding or adults of reproductive potential not employing a highly effective method of birth control which is defined as a birth control which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly
- •- Patients presenting with an AHNMD requiring immediate cytoreductive therapy or targeted drugs (other than midostaurin)
- •- patients who have demonstrated relapse to 3 or more prior regimens of SM treatment
研究者
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