A Phase I, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administrated Every 3 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
- 1
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
Primary Objective:
- To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors.
Secondary Objectives:
- To assess the safety profile of intravenous (IV) aflibercept when administered in combination with docetaxel
- To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in combination
- To make a preliminary assessment of antitumor effects of the combination of docetaxel plus aflibercept in patients with evaluable disease
- To evaluate the immunogenicity of IV aflibercept
- To measure endogenous free Vascular Endothelial Growth Factor (VEGF)
详细描述
The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after the last aflibercept administration. Patients will be administered aflibercept in combination with docetaxel until when/if a definitive treatment discontinuation criterion is met such as progressive disease, unacceptable toxicity or patient refusal to continue.
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
- 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
Aflibercept/ docetaxel
Patients with advanced cancer will receive different doses of aflibercept in combination with approved dose of docetaxel.
Aflibercept 4 or 6mg/kg over 1 hour IV immediately followed by Docetaxel 75mg/m2 IV over 1 hour on Day 1, every 3 weeks
干预措施: Aflibercept (AVE0005) (Drug)
Aflibercept/ docetaxel
Patients with advanced cancer will receive different doses of aflibercept in combination with approved dose of docetaxel.
Aflibercept 4 or 6mg/kg over 1 hour IV immediately followed by Docetaxel 75mg/m2 IV over 1 hour on Day 1, every 3 weeks
干预措施: Docetaxel (XRP6976) (Drug)
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: 3 weeks (cycle 1)
次要结局
- Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities(Up to 30 days after last administration within a maximum follow up of 18 months)
- Pharmacokinetic parameters of aflibercept(up to last aflibercept administration +90 days)
- Pharmacokinetic parameters of docetaxel(cycle 1)
- Tumor response rate as calculated by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)(up to a maximum follow-up of 18 months)
- Immunogenicity of Aflibercept(up to last aflibercept administration+90 days)
- Endogenous free VEGF(up to last aflibercept administration+30 days)