NCT00550017终止1 期
A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subjects With Advanced Cancer (Schedule 2)
Bristol-Myers Squibb2 个研究点 分布在 2 个国家目标入组 39 人开始时间: 2007年12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
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493)
研究概览
简要总结
The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion)
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
- •Advanced cancer, excluding cancer in the blood
- •Availability of 10 tumor tissue slides
排除标准
- •Known brain metastases
- •Severe nerve damage
- •Significant cardiovascular disease
- •Inadequate blood counts
- •Inadequate liver or kidney function
- •Inadequate thyroid function or uncontrolled thyroid disease
研究组 & 干预措施
1
Experimental
干预措施: Epofolate (Drug)
结局指标
主要结局
To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493)
时间窗: at the end of the study
次要结局
- To evaluate the safety and exposure levels of Epofolate (BMS-753493) in the body and the anticancer activity of Epofolate (BMS-753493)(every 21 days)
研究者
研究点 (2)
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