A Phase II Clinical Study of GC1118 in Recurrent Glioblastoma Patients With High Epidermal Growth Factor Receptor (EGFR) Amplification
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
详细描述
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •19 years or older
- •patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)
- •high EGFR amplification
- •available archive tumor sample(s)
- •Karnofsky performance status (KPS) > 70
- •life expectancy > 3 months
- •adequate end-organ function
- •patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1)
排除标准
- •patients who had EGFR target agent(s) before screening
- •patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease)
- •patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks
- •patients who had investigation drug(s) within previous 4 weeks
- •patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer)
- •patients who had severe infection within previous 4 weeks
- •HIV infection
- •patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks
- •clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc)
- •pregnancy or breast-feeding
研究组 & 干预措施
single group
GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles, or till progression or uncontrolled toxicity.
干预措施: GC1118 (Drug)
结局指标
主要结局
Progression-free survival
时间窗: at 6 months
survival time from screening to progression defined by RANO criteria
次要结局
- overall survival(6 months, 12 month)
- overall response rate(up to 30months)
- Exploration of predictive/prognostic biomarkers(up to 30 months)
研究者
Se-Hoon Lee
Professor
Samsung Medical Center