NCT02567331已完成4 期
An Open-label Study of the Safety, Tolerability, and Response Rate of Xeloda in Treatment-naïve Patients With Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This study will evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 28 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients greater than or equal to (>=) 18 years of age
- •Metastatic colorectal cancer
排除标准
- •Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease
- •Central nervous system and bone metastases
- •Moderate or severe renal impairment
- •Clinically significant cardiac disease
- •Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
- •Malignancy within the last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix
研究组 & 干预措施
Capecitabine
Experimental
Participants will receive oral capecitabine 1250 milligrams per square meter (mg/m^2) twice daily for 14 days followed by 7 day rest period for 6 cycles.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: up to approximately 1.5 years
Response rate, ie, percentage of participants with complete, partial, and overall response
时间窗: up to approximately 1.5 years
次要结局
- Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n(up to approximately 1.5 years)
研究者
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