NCT00824161终止2 期
A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Percentage of Progression Free Survival
研究概览
简要总结
The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109
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 colorectal adenocarcinoma
- •Received prior therapy, at least two regimens, containing a fluoropyrimidine, oxaliplatin, and irinotecan
- •Have at least one measurable tumor, as defined by RECIST
- •Must be capable of maintaining a central venous line access
排除标准
- •Had previous anti-tumor therapy in the 3 weeks prior to study entry
- •Have not recovered from all toxicities (excluding alopecia) from prior therapy to baseline or ≤grade 1 prior to study entry
- •Have another malignancy in the past 3 years except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
研究组 & 干预措施
1
Experimental
TAS-109
干预措施: TAS-109 (Drug)
结局指标
主要结局
Percentage of Progression Free Survival
时间窗: From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months.
The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.
次要结局
- Antitumor Activity(From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.)
- Overall Survival(From the initial treatment until 12 months after enrollment of the last patient.)
研究者
研究点 (3)
Loading locations...
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