NCT00921167已完成2 期
A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme
Clinical Research Center for Solid Tumor, Korea1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2009年6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
- 32
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme
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 diagnosed recurrent anaplastic astrocytoma or recurrent glioblastoma multiforme
- •At least 18 years of age
- •Performance status of 0 and 1 on the Eastern Cooperative Oncology Group (ECOG) criteria
- •One or more measurable disease
- •Adequate hematologic (neutrophil count >= 1500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit (UNL)x2.5, bilirubin level =< UNLx1.5, alkaline phosphatase =< UNLx2.5), and renal (creatinine clearance >= 30mL/min)
- •Expected life time more than at least 2 months
- •A patients who signed the informed consent prior to the participation in the study
排除标准
- •A pregnant or lactating patient
- •A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A premenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
- •A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
- •A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
- •Medically uncontrolled serious heart, lung, neurological, psychological, or metabolic disease
- •Uncontrolled serious infection
- •Enrollment in other study within 30 days
- •Hemorrhage on baseline radiologic examination
- •A patient who refused to sign the informed consent
研究组 & 干预措施
Bevacizumab/Irinotecan
Experimental
干预措施: Bevacizumab/Irinotecan (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 6 months, 1 year
次要结局
- Disease-control rate(6 weeks, 12 weeks)
- Objective response rate(6 weeks, 12 weeks)
- Overall survival(6 months, 1 year)
- Adverse event(3 weeks, 6 weeks, 9 weeks, 12 weeks)
研究者
研究点 (1)
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