NCT01260506已完成1 期
Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
Vascular Biogenics Ltd. operating as VBL Therapeutics4 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2010年12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
- 75
- 试验地点
- 4
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma;
- •Measurable disease by RANO criteria;
- •Disease progression or recurrence following standard of care treatment with temozolomide and radiation;
- •An interval of at least 4 weeks between prior surgical resection and study enrollment;
- •An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol;
- •Recovered to Grade 1 or less from the toxic effects of any earlier intervention;
- •Karnofsky performance status > 60%
排除标准
- •Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc);
- •Prior stereotactic radiotherapy;
- •Active infection;
- •Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;
- •Subjects who suffered from an acute cardiac event within the last 12 months;
- •Subjects with active vascular disease, either myocardial or peripheral;
- •Subjects with proliferative and/or vascular retinopathy;
- •Subjects with known active second malignancy;
研究组 & 干预措施
VB-111
Experimental
Antiangiogenic and vascular disruptive agent
干预措施: VB-111 (Drug)
VB-111
Experimental
Antiangiogenic and vascular disruptive agent
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Overall Survival
时间窗: From date of study entry until the date of death from any cause (up to 10 years)
次要结局
- Progression Free Survival(6 months)
研究者
研究点 (4)
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