NCT00919737已完成1 期
A Phase 1/2, Multicenter, Non-Randomized, Open Label Clinical Trial of NPC-08 Implant in Patients Undergoing Surgery for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme.
Nobelpharma1 个研究点 分布在 1 个国家目标入组 24 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
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Overall survival to 12 months
研究概览
简要总结
The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the treatment of newly-diagnosed malignant glioma and 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged between 18 and 65 years;
- •Radiographic evidence on cranial MRI of a single contrast-enhancing unilateral supratentorial cerebral tumor;
- •Karnofsky Performance Score of 60 or higher;
- •Willing to practice an effective method of birth control for at least 12 months after wafer implantation surgery;
排除标准
- •More than one focus of tumor or tumor crossing the midline, as assessed by coronal cranial MRI scan;
- •Prior radiotherapy to the brain;
- •Prior chemotherapy for the malignant glioma before the baseline evaluation, or patients who were being treated with chemotherapeutic agents;
- •Known hypersensitivity to nitrosoureas;
- •Participation in any other investigational protocol in the previous 6 months for any type of malignancy;
研究组 & 干预措施
NPC-08
Experimental
干预措施: NPC-08 (Drug)
结局指标
主要结局
Overall survival to 12 months
时间窗: 12 months
次要结局
- Progression-free survival(12 months)
研究者
研究点 (1)
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