An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 100
- 主要终点
- Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation
研究概览
简要总结
This is an open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this study is to provide additional information about the safety profile of Regorafenib.
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
- •Male or female subjects >/= 18 years of age
- •Life expectancy of at least 3 months
- •Histological or cytological documentation of adenocarcinoma of the colon or rectum
- •Subjects with metastatic colorectal cancer (Stage IV)
- •Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab if KRAS WT (WT: wild-type i.e. no KRAS mutation)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements
- •Women of childbearing potential and men must agree to use adequate contraception since signing of the inform consent (IC) form until at least 3 months after the last study drug administration
排除标准
- •Prior treatment with regorafenib
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
- •Pregnant or breast-feeding subjects
- •Congestive heart failure >/= New York Heart Association (NYHA) class 2
- •Myocardial infarction less than 6 months before start of study drug
- •Ongoing infection > Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
- •Renal failure requiring hemo-or peritoneal dialysis
研究组 & 干预措施
Regorafenib
Regorafenib, 40 mg tablets
干预措施: Regorafenib (Stivarga, BAY73- 4506) (Drug)
结局指标
主要结局
Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation
时间窗: Up to 6 months
Number of participants with serious adverse events as a measure of safety and tolerability
时间窗: Up to 6 months
Number of death
时间窗: Up to 6 months
Progression-Free Survival (PFS)
时间窗: Up to 6 months
The PFS is defined as the time from date of treatment assignment (i.e., date of first treatment) to date of first observed disease progression or death due to any cause, if death occurs while the subject is in the study (that is, by the last visit including during the safety follow-up visit date), and before progression is observed.
Number of participants with adverse events as a measure of safety and tolerability
时间窗: Up to 6 months
次要结局
未报告次要终点