An Open-label, Phase II Study of Capecitabine Plus Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Overall objective response rate
研究概览
简要总结
This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV) gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The anticipated time on study treatment is 3 to 12 months, and the target sample size is 56 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants 18 to 75 years of age
- •Locally advanced or metastatic pancreatic cancer
排除标准
- •Prior chemotherapy for pancreatic cancer
研究组 & 干预措施
Capecitabine + Gemcitabine
Participants will receive oral capecitabine (830 milligrams per meter-squared [mg/m^2]) twice daily (BID) as intermittent treatment (Days 1 to 21 every 4 weeks [q4w]) along with IV infusion of gemcitabine (1000 mg/m^2) once weekly as intermittent treatment (4-week cycles of 3-week treatment period and 1-week rest period).
干预措施: Capecitabine (Drug)
Capecitabine + Gemcitabine
Participants will receive oral capecitabine (830 milligrams per meter-squared [mg/m^2]) twice daily (BID) as intermittent treatment (Days 1 to 21 every 4 weeks [q4w]) along with IV infusion of gemcitabine (1000 mg/m^2) once weekly as intermittent treatment (4-week cycles of 3-week treatment period and 1-week rest period).
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall objective response rate
时间窗: At the end of 6 cycles (24 weeks)
次要结局
- Time to disease progression(Up to approximately 3.5 years)
- Duration of response(Up to approximately 3.5 years)
- Overall survival(Up to approximately 3.5 years)
- Time to response(Up to approximately 3.5 years)
- Time to treatment failure(Up to approximately 3.5 years)
- Incidence of adverse events(Up to approximately 3.5 years)