A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 580
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Capecitabine-tesetaxel
21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
干预措施: Tesetaxel (Drug)
Capecitabine-tesetaxel
21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
干预措施: Capecitabine (Drug)
Capecitabine-placebo
21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
干预措施: Placebo (Drug)
Capecitabine-placebo
21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
干预措施: Capecitabine (Drug)
结局指标
主要结局
Overall survival
时间窗: When at least 508 events of death have occurred, which is estimated will occur 12 months after the date of randomization of the last patient
次要结局
- Disease control rate(Estimated will be assessed 12 months after the date of randomization of the last patient)
- Progression-free survival(Estimated will be assessed 12 months after the date of randomization of the last patient)
- Response rate in patients with measurable disease(Estimated will be assessed 12 months after the date of randomization of the last patient)
- Incidence of adverse events(Through 30 days after the last dose of study medication)