A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Aflibercept in Combination With FOLFIRI Administrated Every 2 Weeks in Chinese Patients With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU)
研究概览
简要总结
Primary Objective:
To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.
Secondary Objectives:
- To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus aflibercept in patients with measurable disease (RECIST 1.1).
- To evaluate the immunogenicity of IV aflibercept.
详细描述
Total duration of the study per patient is in the range of 17 to 29 weeks.
This trial is being conducted in China, where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".
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
- Treatment
- 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
Cohort 1
aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks
干预措施: Aflibercept AVE0005 (Drug)
Cohort 1
aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks
干预措施: Leucovorin (Drug)
Cohort 1
aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks
干预措施: Irinotecan (Drug)
Cohort 1
aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU)
时间窗: Up to last aflibercept administration + 90 days
Number of patients with standard safety assessments (adverse events and laboratory tests)
时间窗: Up to last treatment + 30 days
次要结局
- Anti-aflibercept antibody detection(Up to last aflibercept administration + 90 days)
- Anti-tumor activity assessment - duration response(Up to 17 Weeks)
- Anti-tumor activity assessment - overall response rate(Up to 17 Weeks)