A Phase Ib, Multi-center, Open-label Study of Epitinib Succinate (HMPL-813) in Treating Patients With Glioblastoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
This is an open-label study, to evaluated epitinib, which is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of EGFR may provide a novel mechanism in treating glioblastoma.
详细描述
Epitinib could cross BBB and show its efficacy in brain metastasis tumors. Patients with histologically confirmed glioblastoma; standard treatment failed or no standard treatment as well as EGFR gene amplication are eligible. Patients will receive epitinib 120mg or 160mg epitinib daily. Epitinib is orally administered qd until patients reach intolerance or progression of disease. Tumor assessment takes place every 4 weeks. Simon two stage design was used, estimated making sample size of 35 cases.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed glioblastoma
- •Standard treatment failed or no standard treatment
- •EGFR gene amplification
- •Clearly measurable lesions (according to Response Assessment in Neuro-Oncolog (RANO))
- •Eastern Cooperative Oncology Group (ECOG) score ≤2
排除标准
- •Use of Antiepileptic drugs were used] within 2 weeks before enrollment
- •Immunotherapy, anti-angiogenesis or EGFR TKI and its downstream pathway signaling molecules and other targeted drugs within 4 weeks before enrollment; temozolomide chemotherapy, cranial radiotherapy or other systemic anti-tumor therapy within 3 weeks before enrollment
- •Previous toxic effects of anticancer therapy have not yet been recovered (defined as not restored to 0 or 1 level, except alopecia) or have not been fully recovered from previous surgery
- •Uncontrolled active infections such as acute pneumonia, Hepatitis B Virus (HBV) and so on
- •Eye disease or dry eye syndrome history
- •Positive pregnancy tested result
研究组 & 干预措施
single arm
This is a single arm study. It is an open-label study. The intervention is eptinib succinate.
干预措施: epitinib succinate (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: 6 months
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
次要结局
未报告次要终点