An Open Label, Dose Escalation, Safety and Pharmacokinetic Phase 1 Study With AVE8062 Administered as a 30 Minutes Intravenous Infusion Followed by Docetaxel Administered as an 1 Hour Intravenous Infusion 24 Hours-Apart 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
- 58
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
Primary Objective:
To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered sequentially on D1 & D2 respectively every 3 weeks in patients with advanced solid tumors.
Secondary Objectives:
- To define the overall safety profile of the combination.
- To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when administered in combination.
- To evaluate anti-tumor activity of the combination.
- To evaluate potential predictive biomarkers.
The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The objective to analyse a set of biological biomarkers in order to identify a potential predictive signature of efficacy for AVE8062 in combination with docetaxel.
详细描述
The duration of study for each patient will include 4-week screening phase prior to first inclusion of study drug, 21-day study treatment cycles, end of treatment visit and follow-up phase. Each patient will be treated until disease progression, unacceptable toxicity or other study discontinuation criteria.
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 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
AVE8062 / Docetaxel
AVE8062 30-minute IV, 11.5 to 42 mg/m2, followed by Docetaxel, 1-hour IV, 75 and 100 mg/m2 in 3-week cycles until disease progression or unacceptable toxicity or study discontinuation criteria
干预措施: AVE8062 (Drug)
AVE8062 / Docetaxel
AVE8062 30-minute IV, 11.5 to 42 mg/m2, followed by Docetaxel, 1-hour IV, 75 and 100 mg/m2 in 3-week cycles until disease progression or unacceptable toxicity or study discontinuation criteria
干预措施: Docetaxel (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLTs)
时间窗: 3 weeks (cycle 1)
次要结局
- Plasma concentration of docetaxel(Before docetaxel infusion (corresponding to 24 hours post AVE8062 infusion), 15 minutes before the end of docetaxel infusion, 15 and 45 minutes post docetaxel infusion (cycle 1))
- Number of Participants with Adverse Events(Up to disease progression or unacceptable toxicity or study discontinuation criteria (median treatment of 4 cycles))
- Plasma concentration of AVE8062 and its metabolite(Before AVE8062 infusion, immediately prior to the end of AVE8062 infusion, 5, 10, 25, 45 and 60 minutes then 2, 4, 6, 8-10 and 24 hours post AVE8062 infusion (cycle 1))
- Response evaluation criteria in solid tumors (RECIST) defined objective response(Up to disease progression or unacceptable toxicity or study discontinuation criteria (median treatment of 4 cycles))
- Biomarkers expression profile of each patient in order to identify preliminary correlation with antitumor activity of the combination treatment in patients with available pre-treatment biopsy(End of treatment or until disease progression or unacceptable toxicity or study discontinuation criteria)