Clinical pharmacology study to evaluate the pharmacokinetics, safety and efficacy of multi-targetted tyrosine kinase inhibitor regorafenib in Japanese patients with advanced colorectal cancer. - Clinical pharmacology study of regorafenib in Japanese patients with colorectal cancer.

Showa University School of Medicine0 个研究点目标入组 100 人开始时间: 2014年5月12日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)Known history of interstitial pneumonia or pulmonary fibrosis. 2)Ongoing severe infection. 3)Prior treatment with regorafenib. 4)Unstable angina and Myocardial infarction less than 3 months before start of study drug. 5)Patients with severe complications (incontrollable diabetes mellitus or liver cirrhosis). 6)Concurrent cancer that is distinct in primary site. 7)Psychological condition that may interfere with the patient's participation in the study. 8)Pregnant patients. Men and women who want to make baby. 9)Patients with severe drug allergy or those who had severe drug allergy in the past. 10)Concomitant use of CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampin, phenobarbital, ketoconazole and clarithromycin). 11)Concomitant use of proton pump inhibitor and histamine H2-receptor antagonist. 12)Contraindication to regorafenib. 13)Patients who are not appropriate to participate in the study safely.

发起方

Showa University School of Medicine