A phase IV study to investigate the safety and efficacy of regorafenib in Indianpatients with metastatic colorectal cancer (mCRC) - CORA

Bayer AG0 个研究点目标入组 100 人开始时间: 待定最近更新: 2023年4月3日

试验速览

暂无简介。

•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.

•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

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