NCT00430144已完成2 期
A Phase II Study of Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix
Sokbom Kang1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年1月最近更新:
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
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- overall response rate of belotecan (CKD-602)
研究概览
简要总结
-list item one, The purpose of this study is to evaluate the overall response rate of belotecan (CKD-602) in recurrent or progressive carcinoma of uterine cervix
详细描述
- list item one, to evaluate toxicities of Belotecan
- list item two, to evaluate duration of primary response for responding patients
- list item three, to evaluate time to disease progression
- list item four, to evaluate progression free survival and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, patients with recurrent uterine cervical carcinoma who were unsuitable candidates for curative treatment with surgery and/or radiotherapy.
- •One of the following histologic types
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Adenosquamous carcinoma
- •Clinically measurable disease
- •Performance status of 0, 1, 2 on the ECOG criteria
排除标准
- •Histology of neuroendocrine tumors
- •Patient previously treated with topoisomerase-I inhibitor
研究组 & 干预措施
CKD-602
Experimental
干预措施: Belotecan(CKD-602) (Drug)
结局指标
主要结局
overall response rate of belotecan (CKD-602)
时间窗: 1 week before the start of Cycle 4, 3 weeks later Cycle 6 or at discontinuation of study treatment, and then at least every 3 months
次要结局
未报告次要终点
研究者
Sokbom Kang
director, gynecologic oncology research branch
National Cancer Center, Korea
研究点 (1)
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