An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Paclitaxel and Carboplatin 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
- 18
- 试验地点
- 2
- 主要终点
- The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1
研究概览
简要总结
The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors.
Secondary Objectives:
- To assess the overall safety profiles of the combination therapy
- To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, paclitaxel, and carboplatin when used in combination
- To document the objective tumor response
详细描述
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period.
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
- 20 Years 至 75 Years（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 through 5
AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks
干预措施: Ombrabulin (AVE8062) (Drug)
Cohort - 1 through 5
AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks
干预措施: Paclitaxel (Drug)
Cohort - 1 through 5
AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks
干预措施: Carboplatin (Drug)
结局指标
主要结局
The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1
时间窗: 3 weeks
次要结局
- Pharmacokinetic parameter of ombrabulin: AUC(Day 1-2 at Cycle 1)
- The number of laboratory abnormalities(30 days after the last injection)
- Pharmacokinetic parameter of ombrabulin: Vss(Day 1-2 at Cycle 1)
- Pharmacokinetic parameter of paclitaxel: CL(Day 1-3 at Cycle 1)
- Pharmacokinetic parameter of carboplatin (free and total platinum): Cmax(Day 1-3 at Cycle 1)
- The number of treatment emergent adverse events(30 days after the last injection)
- Pharmacokinetic parameter of RPR258063: t 1/2(Day 1-2 at Cycle 1)
- Pharmacokinetic parameter of RPR258063: Metabolic Ratio(Day 1-2 at Cycle 1)
- Pharmacokinetic parameter of paclitaxel: Vss(Day 1-3 at Cycle 1)
- Pharmacokinetic parameter of ombrabulin: Cmax(Day 1-2 at Cycle 1)
- Pharmacokinetic parameter of RPR258063: tmax(Day 1-2 at Cycle 1)
- Pharmacokinetic parameter of paclitaxel: Cmax(Day 1-3 at Cycle 1)
- The number of serious adverse events(30 days after the last injection)
- Investigator determination of response(30 days after the last injection)
- Pharmacokinetic parameter of carboplatin (free and total platinum): t 1/2(Day 1-3 at Cycle 1)
- Pharmacokinetic parameter of ombrabulin: CL(Day 1-2 at Cycle 1)
- Pharmacokinetic parameter of ombrabulin: t 1/2(Day 1-2 at Cycle 1)
- Pharmacokinetic parameter of RPR258063: Cmax(Day 1-2 at Cycle 1)
- Pharmacokinetic parameter of RPR258063: AUC(Day 1-2 at Cycle 1)
- Pharmacokinetic parameter of paclitaxel: t 1/2(Day 1-3 at Cycle 1)
- Pharmacokinetic parameter of carboplatin (free and total platinum): AUC(Day 1-3 at Cycle 1)
- Pharmacokinetic parameter of carboplatin (free and total platinum): CL(Day 1-3 at Cycle 1)
- Pharmacokinetic parameter of carboplatin (free and total platinum): Vss(Day 1-3 at Cycle 1)
- Pharmacokinetic parameter of paclitaxel: AUC(Day 1-3 at Cycle 1)