A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 38
- 主要终点
- Population PK parameters for dactinomycin and VCR
研究概览
简要总结
This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer. Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer.
II. To identify demographic or physiological factors that are determinants of dactinomycin disposition.
III. To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with cancer.
IV. To identify demographic or physiological factors that are determinants of VCR disposition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cancer, including, but not limited to, any of the following:
- •Acute lymphoblastic leukemia
- •Ewing sarcoma
- •Rhabdomyosarcoma
- •Soft tissue sarcoma
- •Wilms tumor
- •Due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial
- •Able to comply with study requirements
- •Other concurrent chemotherapeutic agents allowed
排除标准
- 未提供
结局指标
主要结局
Population PK parameters for dactinomycin and VCR
时间窗: Not Provided
Demographic and/or physiological factors that are determinants of dactinomycin and VCR disposition
时间窗: Not Provided
次要结局
- Pharmacogenetic profiles of patients receiving dactinomycin and VCR(Not Provided)
- Correlation between genetic variation in drug metabolizing enzymes and drug transporters and observed drug PKs and PDs in children(Not Provided)
- Correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes(Not Provided)
- Pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic characteristics of dactinomycin and vincristine (VCR)(Not Provided)
- Creation of population PK and PD models to assess the effect of drug exposure on toxicity and outcomes(Not Provided)