NCT00044343已完成2 期
An Open-Label, Multicenter, Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy in Subjects With Metastatic Colorectal Cancer Who Have Progressed on First-Line Therapy With 5-Fluorouracil in Combination With Irinotecan or Oxaliplatin
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 58
- 主要终点
- Tumor response rate (complete or partial).
研究概览
简要总结
The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.
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
- •Provide signed informed consent.
- •Refractory Stage IV metastatic colorectal cancer.
- •Received at least 2 cycles of first-line therapy with intravenous 5-FU (5-fluorouracil) in combination with CPT-11 (irinotecan) and/or oxaliplatin.
- •No more than one prior therapy.
- •Tumor tissue available for testing.
- •4 weeks since first-line cancer regimen.
- •Able to swallow and retain oral medication.
- •Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
- •Adequate kidney and liver function.
- •Adequate bone marrow function.
排除标准
- •Pregnant or lactating female.
- •Conditions that would affect absorption of an oral drug
- •First-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin.
- •Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
- •Severe cardiovascular disease or cardiac (heart) disease requiring a device.
- •Active infection.
- •Brain metastases.
- •Concurrent cancer therapy or investigational therapy.
- •Use of oral or intravenous steroids.
- •Unresolved or unstable, serious toxicity from prior therapy.
- •Prior therapy with an EGFR (Endothelial Growth Factor Receptor) and/or erbB-2 inhibitor.
结局指标
主要结局
Tumor response rate (complete or partial).
时间窗: 6 Months
次要结局
- Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers(6 Month)
研究者
研究点 (58)
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