NCT00656734已完成1 期
A Phase 1, Open-Label, Multicenter Dose-escalation, Multidose Study of MDX1411 Administered Every 14 Days in Subjects With Advanced or Recurrent Clear Cell Renal Cell Carcinoma
Bristol-Myers Squibb13 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2008年4月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 13
- 主要终点
- Determine the safety profile of MDX 1411
研究概览
简要总结
To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).
详细描述
Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. The maximum duration for the study is two and a half years for a total of 17 cycles.
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
- •Histologically confirmed diagnosis of RCC with clear cell component
- •Measurable disease
- •Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy
- •Subjects with treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible
- •At least 28 days since the last chemotherapy
- •At least 28 days before the first dose of MDX 1411 since any major surgery
- •ECOG performance status 0-2
- •No known positivity for human immunodeficiency virus (HIV), Hep B or C
排除标准
- •Previous treatment with any other anti-CD70 antibody
- •Active infection requiring i.v systemic therapy within 28 days before first dose
- •Evidence of bleeding diathesis or coagulopathy
- •Active autoimmune disease requiring immunosuppressive therapy
- •Known current drug or alcohol abuse
- •Any underlying medical condition which will make the administration of MDX 1411 hazardous
- •Psychiatric illness or social situation that would preclude study compliance
结局指标
主要结局
Determine the safety profile of MDX 1411
时间窗: duration of study
Determine the maximum tolerated dose of MDX 1411
时间窗: duration of study
次要结局
- Determine the best overall response rate (BORR)(Day 38-42 of each cycle)
研究者
研究点 (13)
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