NCT00277836终止1 期
A Phase 1 Dose-Escalation Study of Intravenous MST-997 Formulated in Polysorbate 80 Diluent Administered Weekly in Subjects With Advanced Malignant Solid Tumors
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年1月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the safety, tolerability and MTD (maximum tolerated dose) of MST-997.
研究概览
简要总结
MST-997 is a taxane analog with the potential to treat subjects with a variety of tumor types. Preclinical data demonstrated that MST-997 inhibited tumor growth when administered intravenously (IV). This phase 1 dose escalation study is designed to evaluate the safety and tolerability of if IV MST-997 formulated in Polysorbate 80 Diluent can be safely administered on a weekly basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •Documented diagnosis of malignant solid tumor with measurable disease
- •Life expectancy of at least 12 weeks
- •ECOG (Eastern Cooperative Oncology Group) performance status of 0,1,or 2
排除标准
- •Recent major surgery, radiation therapy or anti-cancer treatment
- •History of any other prior malignancy within last 5 years
结局指标
主要结局
To evaluate the safety, tolerability and MTD (maximum tolerated dose) of MST-997.
次要结局
- Preliminary pharmacokinetic information on the pharmacokinetics (during cycle 1) abd anti-tumor activity (assessed approximately every 8 weeks) of on MST-997
研究者
研究点 (1)
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