Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line Treatment for Patients With Advanced Biliary Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Progression free survival
研究概览
简要总结
The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.
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
- •Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
- •Evaluable disease
- •ECOG PS ≤ 2
- •Adequate bone marrow, liver and renal function
排除标准
- •Treatment with more than one prior chemotherapy regimen
- •Known, uncontrolled CNS metastases
- •Baseline peripheral neuropathy ≥ grade
- •Significant circulatory disorders in the past 6 months
- •Concomitant use of phosphodiesterase inhibitors
研究组 & 干预措施
SPI-1620 & Docetaxel
Patients will receive 11 μg/m2 of SPI-1620 intravenously over one minute. Ten minutes after (±2 min) SPI-1620 administration, patients will receive docetaxel 75 mg/m2 intravenous. This regimen will be repeated every 3-weeks cycles until progression or intolerable toxicity.
干预措施: SPI-1620 (Drug)
SPI-1620 & Docetaxel
Patients will receive 11 μg/m2 of SPI-1620 intravenously over one minute. Ten minutes after (±2 min) SPI-1620 administration, patients will receive docetaxel 75 mg/m2 intravenous. This regimen will be repeated every 3-weeks cycles until progression or intolerable toxicity.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression free survival
时间窗: 18 months
次要结局
- Overall response rate(18 months)
- Overall survival(18 months)
- Duration of Response(12 months)
- Safety of SPI-1620 when administered in combination with docetaxel(12 months)