CTRI/2018/06/014371已完成4 期
A phase IV study to investigate the safety and efficacy of regorafenib in Indianpatients with metastatic colorectal cancer (mCRC) - CORA
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent
- •2 Male or female patients (>=18 years of age) with metastatic (Stage IV) colorectal adenocarcinoma confirmed either histologically or cytologically with measurable metastatic disease according to RECIST v. 1.1
- •3 Patients must have PD after receiving the approved standard
- •4 Patients must have ECOG PS of 0 or 1 and a life expectancy of atleast 3 months
- •5 Adequate bone marrow, liver and renal function;
- •6 Women of childbearing potential and men must agree to use adequate contraception.
排除标准
- •1 Unresolved toxicity greater than Grade 1 from prior treatment for
- •2 Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s)
- •3 Subjects unable to swallow oral medications
- •Any malabsorption condition;
- •4 Any medical or surgical conditions within 28 days before start of regorafenib that will interfere with patientâ??s participation in the
研究者
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