NCT02511405已完成3 期
A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined With Bevacizumab vs. Bevacizumab Monotherapy in Patients With Recurrent Glioblastoma
Vascular Biogenics Ltd. operating as VBL Therapeutics57 个研究点 分布在 2 个国家目标入组 252 人开始时间: 2015年8月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 57
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •First or second progression of Glioblastoma;
- •Measurable disease by RANO criteria at progression;
- •Patients ≥18 years of age;
- •Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;
- •Surgery completed at least 28 days before randomization;
- •An interval of at least 12 weeks between prior radiotherapy or at least 23 days from prior chemotherapy, 42 days from nitrosoureas and enrollment in this study;
- •Adequate performance, i.e."Karnofsky Performance Score" of at least 70%;
- •Adequate renal, liver, and bone marrow function according to the following criteria:
- •Absolute neutrophil count ≥1500 cells/ml,
- •Platelets ≥ 100,000 cells/ml,
- •Total bilirubin within upper limit of normal (ULN),
- •Aspartate aminotransferase (AST) ≤ 2.0 X ULN,
- •Serum creatinine level ≤ ULN or creatinine clearance ≥ 50 ml/min for patients with creatinine levels above normal limits (creatinine clearance calculated by the Cockcroft-Gault formula, see Appendix II),
- •PT, PTT (in seconds) not to be prolonged beyond >20% of the upper limits of normal.
排除标准
- •Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab, aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib, etc.);
- •Prior stereotactic radiotherapy;
- •Pregnant or breastfeeding patients;
- •Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
- •Active infection;
- •Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;
- •Expected to have surgery during study period;
- •Patients with active vascular disease, either myocardial or peripheral (i.e. acute coronary syndrome, cerebral stroke, transient ischemic attack or arterial thrombosis or symptomatic peripheral vascular disease within the past 3 months);
- •Patients with known proliferative and/or vascular retinopathy;
- •Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune);
- •Patients with known active second malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and have been disease free for greater than 2 years prior to screening;
- •Patients testing positive to one of the following viruses: HIV, HBV and HCV within the last 6 months;
- •Patients that have undergone major surgery within the last 4 weeks before enrollment;
- •Patients who have received treatment with any other investigational agent within 4 weeks before enrollment.
研究组 & 干预措施
Arm 1
Experimental
VB-111 + Bevacizumab
干预措施: VB-111 + bevacizumab (Drug)
Arm 2
Active Comparator
Bevacizumab
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(To be assessed from date of randomization until the date of disease progression, assessed up to 10 years.)
- Tumor response as measured by RANO Criteria(To be assessed from date of randomization until the date of disease progression, assessed up to 10 years.)
研究者
研究点 (57)
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