NCT01373398已完成1 期
Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.)
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are clinically diagnosed as having stage Ta, T1, histological grade G1, G2 urothelial carcinoma of the bladder
- •Patients who are confirmed to be urinary cytology negative (class I, class II) within 4 weeks prior to the present TURBT.
- •P.S : 0-2 according to the ECOG.
排除标准
- •Patients with a primary and solitary tumor.
- •CIS lesions in the bladder or a history thereof.
- •Grade 3 disease or a history thereof.
- •Patients experiencing recurrence within 3 months following TURBT for prior NMIBC.
- •Patients having stage T1 and high-grade disease.
- •Invasive cancer of T2 or greater, with definite lymph node or other organ metastasis, or a history thereof.
- •Patients who received intravesical chemotherapy/immunotherapy treatment within 6 months prior to the present TURBT.
- •Patients who underwent systemic chemotherapy or radiotherapy whose field of exposure included the bladder.
- •Patients with suspected bladder perforation at the time of the present TURBT.
- •A complication of a malignant tumor of the upper urinary tract or urethra, or a history thereof.
- •Malignancy within 5 years other than NMIBC (except thyroid cancer)
- •A serious viral or bacterial infection within the last 4 weeks.
结局指标
主要结局
Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.)
时间窗: 14 weeks
次要结局
- pharmacokinetics assessment of EO9 and it's metabolites in blood and urine(before, 30, 55, 90 mins of EO9 instillation)
研究者
研究点 (4)
Loading locations...
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