NCT00092001已完成2 期
A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Overall confirmed objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.
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
- •Histologically confirmed advanced or metastatic Non-Small Cell Lung Cancer that cannot be cured with surgery, radiation, or combination thereof
- •No more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy
- •Evidence of measurable disease by radiographic technique
- •Male or Female, 18 years or older
- •ECOG performance status of 0 or 1
- •Resolution of all acute toxicities of prior therapies
- •Adequate organ function
排除标准
- •Major surgery or radiation therapy within 4 weeks
- •Severe hemorrhage within 4 weeks
- •Previous treatment with anti-angiogenesis agents
- •Diagnosis of second malignancy within last five 5 years
- •History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
- •Known HIV
- •Serious acute or chronic illness
- •Current treatment on another clinical trial
- •Pregnant or breastfeeding
研究组 & 干预措施
1
Experimental
干预措施: Sunitinib (Drug)
结局指标
主要结局
Overall confirmed objective response rate (ORR)
时间窗: From screening until at least 28 days beyond discontinuation of study treatment.
次要结局
- Progression-free survival (PFS)(From screening until disease progression or discontinuation of study)
- Time to progression (TTP)(From screening until disease progression or discontinuation of study)
- Duration of response (DR)(From screening until disease progression or discontinuation of study)
- Overall survival (OS)(From screening until disease progression or discontinuation of study)
- Probability of survival at 1 year(From screening until disease progression or discontinuation of study)
研究者
研究点 (1)
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