EUCTR2013-001291-38-DE进行中（未招募）1 期
Open, non-controlled, dose escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability and toxicity of volasertib in paediatric patients from 2 years to less than 18 years of age with acute leukaemia or advanced solid tumour, for whom no effective treatment is known - Determination of MTD of volasertib in paediatric patients with advanced cancer
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
- •- paediatric patients with leukaemia or advanced solid tumours including lymphomas (age 2 - less than 18 years) for whom no further treatment is known
- •- Lansky score > 60 for children 2 to less than 12 years
- •- Karnofsky score > 60 for children aged 12 or older
- •- life expectancy of at least 6 weeks as judged by the investigator
- •-parents or legal guardians have given written informed consent and informed assent suitable for the respective age group obtained
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- patient eligible for other anti-leukaemic therapy with curative intent or effective therapy known for solid tumour therapy
- •- presence of cardiac disease (left ventricular shortening fraction by echocardiography < 30 %)
- •- symptomatic CNS involvement of the malignant disease
- •- primary CNS tumour
- •- inadequate lab parameters
- •- inadequate venous access
- •- QTc prolongation
- •- pregnancy, breastfeeding
- •- other diseases or CTs that might interfere with evaluation of safety
研究者
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