NCT00090025终止3 期
A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 248
- 试验地点
- 59
- 主要终点
- To compare survival duration for XL119 and 5-FU/LV treated subjects
研究概览
简要总结
The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach
- •18 years or older
- •Life expectancy of at least 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3
- •Willing and able to sign informed consent
- •Sexually active men and women must use an accepted and effective method of contraception (including barrier contraception with spermicide)
- •Women of child-bearing age must have a negative pregnancy test
- •Laboratory criteria
排除标准
- •Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study)
- •Unstable angina, or class III or IV New York Heart Association heart disease
- •Central nervous system metastases
- •Uncontrolled diabetes mellitus
- •Uncontrolled seizure disorder
- •Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment
- •Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation
- •Pregnant or breast-feeding
- •A known history of human immunodeficiency virus (HIV) infection
研究组 & 干预措施
becatecarin
Experimental
becatecarin
干预措施: becatecarin (Drug)
5-FU Plus Leucovorin (LV)
Active Comparator
5-Fluorouracil (5-FU) Plus Leucovorin (LV)
干预措施: 5-Fluorouracil Plus Leucovorin (Drug)
结局指标
主要结局
To compare survival duration for XL119 and 5-FU/LV treated subjects
时间窗: time to death
次要结局
- To determine time to progressive disease for XL119 and 5-FU/LV treated subjects, to evaluate clinical benefit for XL119 and 5-FU/LV treated subjects, and to assess the safety profile of XL119(time to progressive disease)
研究者
研究点 (59)
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