ISRCTN57509500已完成2 期
Phase II pharmacokinetic study to assess the age-dependency in the clearance of doxorubicin in paediatric patients with solid tumours and leukaemia
ewcastle upon Tyne Hospitals NHS Trust (UK)0 个研究点目标入组 100 人开始时间: 2011年9月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •1. Patients less than or equal to 17 years of age
- •2. Plan to receive at least 2 cycles of doxorubicin
- •3. Must be enrolled in a national or European protocol for treatment of Wilms 4.Turmours, Neuroblastoma, Soft tissue sarcome, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol or patients under 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy.
- •5. Patients, parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations
- •6. Patients that are able to understand should provide assent to participate in the trial
- •7. Life expectancy is >3 months
- •8. Karnofsky performance status of >/=70%
- •9. Additional blood withdrawal is acceptable to the patient. (the decision is left to the investigator)
- •10. Either male or female
排除标准
- •Prior cardiac problems
研究者
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