A Randomized, Open Label Trial to Assess the Steady State Pharmacokinetics of Avastin Given With Either XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Weekly Steady-state Exposure of Bevacizumab
研究概览
简要总结
This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •adult patients, >=18 years of age;
- •adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease;
- •>=1 target lesion.
排除标准
- •patients who have previously received systemic treatment for advanced or metastatic disease;
- •patients who have received adjuvant treatment for non-metastatic disease in past 3 months;
- •previous therapy with oxaliplatin or Avastin.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: XELOX (Drug)
2
干预措施: bevacizumab [Avastin] (Drug)
2
干预措施: FOLFOX-4 (Drug)
结局指标
主要结局
Weekly Steady-state Exposure of Bevacizumab
时间窗: Up to 48 weeks
Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.
次要结局
- Time Zero to Last Measurable Plasma Concentration of Bevacizumab(Up to 48 weeks)
- Steady-state Exposure of Bevacizumab From Time Zero to Tau(Up to 48 weeks)
- Maximum Serum Concentration of Bevacizumab at Steady State(Up to 48 weeks)
- Minimum Serum Concentration of Bevacizumab at Steady State(Up to 48 weeks)
- Serum Clearance of Bevacizumab(Up to 48 weeks)
- Time of Maximum Serum Concentration of Bevacizumab(Up to 48 weeks)
- Volume of Distribution of Bevacizumab at Steady State(Up to 48 weeks)
- Terminal Half-life of Bevacizumab(Up to 48 weeks)