NCT01095926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
University Hospital Muenster23 个研究点 分布在 4 个国家目标入组 101 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 23
- 主要终点
- Assess age-dependency in pharmacokinetics of doxorubicin in paediatric patients with solid tumours and leukaemia
研究概览
简要总结
Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity .
详细描述
- Paediatric patients up to the age of 17 years will be included. Number and time points of PK sampling will depend on age and tumour type.
- PK samples will be collected from two doxorubicin administrations. Analyzing samples from two doxorubicin administrations will allow distinguishing between interindividual, intraindividual and residual variability.
- Doxorubicin and its major metabolite doxorubicinol will be measured in plasma using HPLC
- In addition, the natriuretic peptide BNP and the precursors NT-pro ANP and NT-proBNP as well as troponin T will be measured in plasma up to 28 days after doxorubicin administration to evaluate their use as clinical markers for cardiotoxicity.
- A data set of max 5 samples (3 +2 (in the 1st + 2nd Doxorubicin sampling periods)) will be collected in the younger children (< 3 years) and a data set of max. 8 samples ( 5 + 3) will be collected in the older children. Samples will be taken at predefined time points/ time intervals.
- An additional DNA sample will be taken and analyzed for genetic polymorphisms. The influence of genotype on pharmacokinetics and metabolism will be investigated by appropriate statistical methods, including population pharmacokinetic analyses. Genes to study would include MDR1 and SLC22A16, both involved in the transport of doxorubicin and AKR1A1 and CBR1, both involved in the reduction of doxorubicin to doxorubicinol. Selected genotypes will be incorporated as covariates into the population pharmacokinetic models developed. The potential impact of genetic variation will be evaluated in the context of other sources of variability such as age, weight, gender etc
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 Or 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.
- •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
排除标准
- •prior cardiac problems
研究组 & 干预措施
Doxorubicin
Experimental
干预措施: doxorubicin (Drug)
结局指标
主要结局
Assess age-dependency in pharmacokinetics of doxorubicin in paediatric patients with solid tumours and leukaemia
时间窗: 24h
Measure doxorubicin and doxorubicinol concentration in blood plasma. Collect samples at two different doxorubicin infusions.
次要结局
- Assess interindividual, intraindividual and residual variability of PK parameters in children(24h)
- Assess relationship between PK parameters and patient characteristics(24h)
- Explore in a preliminary fashion genetic polymorphisms that may influence doxorubicin clearance(5 years)
- Evaluate the potential role of natriuretic peptides and troponin as indicators for subclinical cardiotoxicity(1 month)
研究者
研究点 (23)
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