EUCTR2012-003138-17-IT进行中（未招募）1 期
A double-blind, placebo-controlled, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care (SOC) +/-continuous bevacizumab treatment following progression of disease (PD) in patients with glioblastoma (GBM) after first (1st)-line treatment with radiotherapy, temozolomide and bevacizumab
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 510
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have provided written informed consent.
- •Age = 18 years .
- •Karnofsky performance status (KPS) = 60.
- •Newly diagnosed GBM
- •Craniotomy or intracranial biopsy site must be adequately healed. Study treatment should be initiated > 28 days and = 49 days following the last surgical procedure.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 398
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •Any prior chemotherapy for GBM and low grade astrocytomas.
- •Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field.
- •Prior or current anti-angiogenic treatment (i.e. anti-VEGF or VEGFR therapies or tyrosine kinase inhibitors).
- •Evidence of recent brain haemorrhage
- •Acute cardiac disease
研究者
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