An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Docetaxel and Cisplatin 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
- 11
- 试验地点
- 3
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
Primary Objective:
- To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of ombrabulin in combination with docetaxel and cisplatin administered every 3 weeks in patients with advanced solid tumors
Secondary Objectives:
- To assess the overall safety profile of the combination therapy
- To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, docetaxel and cisplatin in combination.
- To evaluate anti-tumor activity of the combination therapy
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 30 days after the last infusion of ombrabulin. The patient will continue treatment until disease progression, unacceptable toxicity, patient's refusal of further treatment.
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
- 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
Ombrabulin/ docetaxel/cisplatin
AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
干预措施: OMBRABULIN (AVE8062) (Drug)
Ombrabulin/ docetaxel/cisplatin
AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
干预措施: cisplatin (Drug)
Ombrabulin/ docetaxel/cisplatin
AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
干预措施: docetaxel (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: 3 weeks (cycle 1)
次要结局
- Pharmacokinetic profiles of all study drugs and AVE8062 active metabolite based on PK parameters (Cmax, AUC, t1/2, CL, Vss).(Cycle 1: Day 1 and 3; up to Cycle 4: Day 1)
- Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities(on-treatment period + 30 days)
- Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)(on-treatment period + 30 days)