NCT00615446已完成1 期
A Phase 1 Study Of SU011248 And Gemcitabine 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
- 44
- 试验地点
- 1
- 主要终点
- To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine
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 gemcitabine 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 gemcitabine or SU011248
- •Hypertension that cannot be controlled by medications
研究组 & 干预措施
A
Experimental
干预措施: SU011248; Gemcitabine (Drug)
结局指标
主要结局
To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine
时间窗: From screening until at least 28 days beyond discontinuation of study treatment
次要结局
- To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered(From screening until at least 28 days beyond discontinuation of study treatment)
- To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease(From screening until at least 28 days beyond discontinuation of study treatment)
研究者
研究点 (1)
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