A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in Combination With Pazopanib in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.
研究概览
简要总结
To determined what dose of topotecan can be safely given with daily pazopanib.
详细描述
A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in combination with Pazopanib in Subjects with Advanced Solid Tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older 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
Treatment Arm A
Daily oral pazopanib in combination with weekly oral topotecan. Initially rising dose to determine the maximum tolerated dose: finally an expanded cohort treated at the maximum tolerated dose.
干预措施: topotecan (Drug)
Treatment Arm A
Daily oral pazopanib in combination with weekly oral topotecan. Initially rising dose to determine the maximum tolerated dose: finally an expanded cohort treated at the maximum tolerated dose.
干预措施: pazopanib (Drug)
Treatment Arm B
Daily oral pazopanib in combination with oral topotecan given for 5 consecutive days every 21 days. Initially rising dose to determine the maximum tolerated dose; finally an additional cohort of patients treated at the maximum tolerated dose.
干预措施: topotecan (Drug)
Treatment Arm B
Daily oral pazopanib in combination with oral topotecan given for 5 consecutive days every 21 days. Initially rising dose to determine the maximum tolerated dose; finally an additional cohort of patients treated at the maximum tolerated dose.
干预措施: pazopanib (Drug)
结局指标
主要结局
First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.
时间窗: 5 weeks
次要结局
- Indications of efficacy through tumour shrinkage. Specific biomarker analysis.(12 weeks)