NCT00095537已完成1 期
Phase I Study of BMS-599626 in Patients With Advanced Solid Malignancies, Including Malignancies That Express HER2 at the Maximum Tolerated Dose and/or Recommended Phase II Dose
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Det. the max tolerated dose,biologically active doses & recommended phase 2 dose of BMS-599626 when adm. as a daily oral dose to pts with HER2 expressing-metastatic solid tumors who have progressed on or following standard therapy
研究概览
简要总结
The purpose of this trial is to identify the highest oral dose of BMS-599626, a drug that is directed against EGFR and HER2 proteins, that can be given safely on a daily schedule of 21 days with a 7 day rest period in patients with cancer who no longer benefit from other commonly used treatments. The study will also test for other proteins that may be affected by BMS-599626; and the level of study drug in the blood will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Diagnosis of metastatic cancer that has progressed on currently available therapies;
- •At least 3 month life expectancy;
- •Primary cancer must be solid (non-hematologic);
- •Adequate bone marrow, liver & kidney function;
- •Negative pregnancy test.
排除标准
- •Serious, uncontrolled medical disorder;
- •Individuals not willing or able to use an acceptable method to avoid pregnancy for the entire study period and for at least 3 months after the study;
- •Pregnant or breastfeeding women;
- •Patients with known brain metastasis;
- •Uncontrolled or significant cardiovascular disease;
- •Anticancer therapy within 2-6 weeks prior to study drug (depending on the therapy)
研究组 & 干预措施
Phase 1 MTD Study
Experimental
干预措施: panHer (Drug)
结局指标
主要结局
Det. the max tolerated dose,biologically active doses & recommended phase 2 dose of BMS-599626 when adm. as a daily oral dose to pts with HER2 expressing-metastatic solid tumors who have progressed on or following standard therapy
次要结局
- Evaluate the effect of BMS-599626 on biomarkers & predictive markers of HER1/2 in skin metabolic act. through PET imaging & preliminary evidence of anti-tumor act.,determine the effect of gastric acid modifying agents on systemic exposure of BMS-599626
研究者
研究点 (1)
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