Phase II study of dose-escalation of Regorafenib for patients with previously treated metastatic colorectal cancer.
- Conditions
- Previously treated metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000014661
- Lead Sponsor
- Kyoto-Katsura Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Not provided
1. Patients with synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. 2. Case with the history of usage of the Regorafenib. 3. Case with the history of usage of the TAS-102. 4. Patients with uncontrolled hypertension. 5. Patients suffering watery stools or diarrhea. 6. Patients who have gastrointestinal perforation or bleeding. 7. Patients with non-healing wound (excluding central venous reservoir). 8. Patients with infectious disease and febrile condition (over 38 centigrade). 9. Patients who have active hepatitis type B or C. 10. Patients with chronic heart failure of NYHA Class 2 or worse. 11. Patients with history of cardiovascular events including unstable angina, cardiac infarction, cerebral infarction and pulmonary embolism within 6 months. 12. Patients with ileus or severe intestinal obstruction. 13. Patients with disorders of the central nervous system. 14. Patients with a history of the severe hypersensitivity to regorafenib. 15. Pregnant or lactating woman. 16. Other patients who are unfit for the study as determined by the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method