JPRN-UMIN000013939
Recruiting
未知
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 sites100 target enrollmentMay 12, 2014
ConditionsColorectal Cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Showa University School of Medicine
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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