Clinical pharmacology study to evaluate the pharmacokinetics, safety and efficacy of multi-targetted tyrosine kinase inhibitor regorafenib in Japanese patients with advanced colorectal cancer.
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000013939
- Lead Sponsor
- Showa University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics, progression free survival, response rate, adverse event,
- Secondary Outcome Measures
Name Time Method