An Open-label, Non-randomized, Dose Escalation, Safety and Pharmacokinetic Phase I Study of Ombrabulin (AVE8062) in Combination With Bevacizumab Administered by Intravenous Infusion Every 3 Weeks in Patients With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Incidence of Dose Limiting Toxicities (DLTs) that will define the MTD
研究概览
简要总结
Primary Objective:
- To determine the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of ombrabulin in combination with best tolerated dose of bevacizumab based on the incidence of related Dose Limiting Toxicities (DLTs).
Secondary Objectives:
- To assess the overall safety profile of the combination
- To characterize the pharmacokinetic (PK) profile of both ombrabulin and bevacizumab when given in combination
- To evaluate preliminary evidence of anti-tumor activity
- To assess the pharmacodynamic effect using (Dynamic Contrast Enhanced Ultra-Sound) DCE-US, measuring biomarkers
详细描述
The duration of the study for each patient will include an up to 28-day screening phase, 21-day study treatment cycles, an end of treatment visit with a follow-up period. Each patient will participate in only one dose group and will receive AVE8062 with bevacizumab every 3 weeks until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision.
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
AVE8062/ bevacizumab
The combination of ombrabulin and bevacizumab will be administered every 3 weeks according to the following schedule: One day 1, ombrabulin will be administered as a 30 minutes intravenous (i.v) infusion. Bevacizumab will be administered as a 30-90 minutes i.v. infusion 24 hours after the end of ombrabulin infusion on day 2.
干预措施: Ombrabulin (AVE8062) (Drug)
AVE8062/ bevacizumab
The combination of ombrabulin and bevacizumab will be administered every 3 weeks according to the following schedule: One day 1, ombrabulin will be administered as a 30 minutes intravenous (i.v) infusion. Bevacizumab will be administered as a 30-90 minutes i.v. infusion 24 hours after the end of ombrabulin infusion on day 2.
干预措施: bevacizumab (Drug)
结局指标
主要结局
Incidence of Dose Limiting Toxicities (DLTs) that will define the MTD
时间窗: 3 weeks
次要结局
- Pharmacokinetic parameters of ombrabulin(6 weeks)
- Overall safety profile of the combination(up to a maximum follow-up of 1 year)
- Pharmacokinetic parameters of bevacizumab(6 weeks)
- Preliminary evidence of antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(up to a maximum follow-up of 1 year)
- Pharmacodynamic effect (biomarkers)(cycle 1)