NCT00093730已完成1 期
Phase I Study Of BMS-599626 In Patients With Advanced Solid Malignancies That Express Her2
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- maximum tolerated dose of BMS-599626
研究概览
简要总结
RATIONALE: BMS-599626 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of BMS-599626 in treating patients with metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose, biologically active dose, and recommended phase II dose(s) of BMS-599626 in patients with metastatic HER2/neu-overexpressing primary solid tumors.
Secondary
- Determine the safety and tolerability of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the effect of this drug on biomarkers and predictive markers of HER1 and HER2 in skin and tumor in these patients.
- Evaluate tumor metabolic activity in response to this drug in these patients.
- Determine, preliminarily, evidence of anti-tumor activity of this drug in these patients.
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
- 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
BMS-59926
Experimental
干预措施: BMS-59926 (Drug)
结局指标
主要结局
maximum tolerated dose of BMS-599626
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (1)
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