A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim After Single Administration in Pediatric Solid Tumor/Lymphoma Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- PK parameter
研究概览
简要总结
This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=6 and <19-year-old pediatrics with solid tumor/lymphoma
- •Scheduled for chemotherapy requiring G-CSF support or having given an experience of ANC < 0.5x10^9/L
- •ANC > 0.75x10^9/L, platelet > 75x10^9/L
- •ECOG performance status 0 or 1
排除标准
- •Patients with leukemia, myelodysplastic syndrome or uncontrolled infectious/nervous diseases
- •History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins.
- •Women who are pregnant or lactating
研究组 & 干预措施
Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients
A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
干预措施: Tripegfilgrastim (Drug)
Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients
A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
干预措施: Tripegfilgrastim (Drug)
Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients
A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
干预措施: Tripegfilgrastim (Drug)
Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients
A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
干预措施: Tripegfilgrastim (Drug)
结局指标
主要结局
PK parameter
时间窗: Day 1(Hour 0) ~ Day 21
The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered \[Ctrough\]
次要结局
- PD parameter(Day 1(Hour 0) ~ Day 14)