A prospective Single-center Study of Pharmacokinetics and Pharmacogenetics of Regorafenib in Patients with Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Registration Number
- JPRN-UMIN000032725
- Lead Sponsor
- Cancer Institute Hospital of Japanese Foundation for Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
The exclusion criteria are mainly as follows (regardless of gender): 1. Has synchronous multiple primary cancer within 5 years (except for carcinoma in situ ) 2.Taking CYP3A4 inhibitors or inducers(eg, phenytoin, carbamazepine, rifampin, phenobarbital, ketoconazole, macrolide antibiotics). 3. Has complication as follows a) poorly controlled diabetes b) uncontrolled hypertensions c) cirrhosis, liver failure, renal insufficiency d) intestinal paralysis, ileus e) interstitial lung disease, pulmonary fibrosis, emphysema f) active infection g) cardiac disease h) cerebrovascular disorder, brain metastasis i) hemorrhagic ulcer J) psychiatric disorder 4. Is a pregnant or lactating female 5. Amalgamation of mental disease or psychotic manifestation 6. The investigator considers not suitable for the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint was to evaluate the association between SNPs of UGT1A9 and hand foot syndrome Grade 3.
- Secondary Outcome Measures
Name Time Method