NCT00100685终止2 期
Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- The proportion of patients with a confirmed tumor response at any time during the study
研究概览
简要总结
This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) and is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
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 —（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
Arm 1
Experimental
Volociximab administered intravenously at a dose of 10 mg/kg qowk
干预措施: Volociximab (anti-α5β1 integrin monoclonal antibody) (Drug)
Arm 2
Experimental
Volociximab administered intravenously at a dose of 15 mg/kg qwk
干预措施: Volociximab (anti-α5β1 integrin monoclonal antibody) (Drug)
结局指标
主要结局
The proportion of patients with a confirmed tumor response at any time during the study
时间窗: Any time during the study
次要结局
- Duration of tumor response(Up to 104 weeks)
- Time to disease progression(Up to 104 weeks)
- Pharmacokinetics (PK) of M200(Day 0 through Study Termination)
- Immunogenicity(Day 0 through Study Termination)
研究者
研究点 (3)
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