NCT00174434已完成1 期
A Phase 1 Study Of Paclitaxel In Combination With SU011248 For Patients With Breast Cancer As First-Line Treatment In The Advanced Disease Setting
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
- Pfizer
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Safety of the combination of SU011248 and paclitaxel
研究概览
简要总结
This study is to evaluate the safety of SU011248 in combination with paclitaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.
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
- •Breast cancer with evidence of unresectable, locally recurrent or metastatic disease.
- •Candidate for treatment with paclitaxel.
排除标准
- •Prior chemotherapy in the advanced disease setting.
- •HER2 positive disease unless previously treated with trastuzumab.
研究组 & 干预措施
A
Experimental
干预措施: SU011248 (Drug)
A
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Safety of the combination of SU011248 and paclitaxel
时间窗: 9/05-7/07
次要结局
- Pharmacokinetics of each medication(9/05-7/07)
- Objective disease response(9/05-7/07)
- Progression-free survival.(9/05-7/07)
研究者
研究点 (1)
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