A Phase I and Enrichment Study of Low-dose Metronomic Topotecan and Pazopanib in Pediatric Patients With Recurrent or Refractory Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Maximum tolerated dose (MTD) of low dose metronomic (LDM)Topotecan
研究概览
简要总结
This is a phase I, dose escalation study where topotecan will be administered at lower doses given more frequently on a prolonged schedule (low dose metronomic; LDM), in combination with pazopanib administered in a specific dose range. The maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) will be evaluated for LDM topotecan in combination with pazopanib in children with recurrent or refractory solid tumours. Pharmacokinetic and pharmacodynamic studies will be conducted to further define the exposure to and activity of LDM topotecan in combination with pazopanib.
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
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Topotecan and Pazopanib
Low dose Topotecan will be given metronomically in combination with Pazopanib at the dose level assigned at study entry
干预措施: Topotecan and Pazopanib (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of low dose metronomic (LDM)Topotecan
时间窗: Dose limiting toxicities (DLT) will be identified during the first cycle of therapy (28 days)
MTD is dependent on the number of subjects who experience a DLT at a given dose level
Recommended phase 2 dose (RP2D) of LDM Topotecan
时间窗: Dose limiting toxicities (DLT) will be identified during the first cycle of therapy (28 days)
The RP2D will be defined as the highest dose, at or below the MTD, at which the median number of cycles tolerated by subjects is ≥ 3.
次要结局
- Anti-tumour activity of LDM Topotecan in combination with Pazopanib(24 months)
- Anti-angiogenic activity of LDM Topotecan and Pazopanib(24 months)
- Pharmacokinetics of LDM Topotecan and Pazopanib(24 months)
研究者
Jim Whitlock
Chief, Division of Haematology/Oncology
The Hospital for Sick Children