NCT00618124已完成1 期
A Phase 1 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine In Patients With Advanced Solid Tumors
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
- 77
- 试验地点
- 1
- 主要终点
- To determine the maximally tolerated dose of SU011248 (dosed continuously or on a 4/2 or 2/1 Schedule) when given in combination with capecitabine.
研究概览
简要总结
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists
- •Patient has good performance status (ECOG 0 or 1)
排除标准
- •Prior treatment with either SU011248 or capecitabine.
- •Hypertension that cannot be controlled by medications
研究组 & 干预措施
A
Experimental
干预措施: SU011248; Capecitabine (Drug)
结局指标
主要结局
To determine the maximally tolerated dose of SU011248 (dosed continuously or on a 4/2 or 2/1 Schedule) when given in combination with capecitabine.
时间窗: From Screening until disease progression or discontinuation of the study
次要结局
- To evaluate the pharmacokinetics of SU011248 and capecitabine when these drugs are co-administered(From Cycle 1, Day 1 until discontinuation of the study)
- To preliminarily assess the antitumor activity of SU011248 and capecitabine in patients with measurable disease(From screening until disease progression or discontinuation of the study)
研究者
研究点 (1)
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