EUCTR2009-011454-17-GB进行中（未招募）1 期
Phase II pharmacokinetic study to assess the age-dependency in the clearance of doxorubicin in paediatric patients with solid tumours and leukaemia - A European paediatric oncology off-patent medicines consortium protocol. - Doxo V1.1
niversitatsklinikum Munster0 个研究点目标入组 100 人开始时间: 2010年6月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •patients = 17 years of age
- •plan to receive at least two cycles of doxorubicin
- •must be enrolled in a national or European protocol for treatment of Wilms Tumours, Neuroblastoma, Soft tissue sarcoma, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol
- •Patients < 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. Treatment with doxorubicin has to be according to that protocol.
- •Patient, parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations. Patients that are able to understand should provide assent to participate in the trial.
- •life expectancy of at least 3 month
- •Karnofsky performance status of = 70%
- •additional blood withdrawal is acceptable for the patient. The decision is left to the investigator
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •prior cardiac problems
研究者
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