NCT00171938终止2 期
Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
研究概览
简要总结
This is an open label clinical trial of imatinib mesylate 800 mg po/day in a population of patients with unresectable, recurrent glioblastoma multiforme. Patients will be treated for up to 12 months
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 documented diagnosis of GBM.
- •Immunohistochemical documentation of expression of PDGFR.
- •Unresectable, recurrent disease by MRI and spectroscopy
排除标准
- •Treatment with any other investigational agents within 28 days of first day of study drug dosing.
- •Concurrent chemotherapy.
- •Concurrent radiotherapy.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
次要结局
- Objective Tumoral Response defined by RECISt criteria performed by MRI
- OS (overall survival)
研究者
研究点 (1)
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