Phase II study of dose-escalation of Regorafenib for patients with previously treated metastatic colorectal cancer.

Phase 2

Recruiting

• Conditions: Previously treated metastatic colorectal cancer

• Registration Number: JPRN-UMIN000014661
• Lead Sponsor: Kyoto-Katsura Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-28
• Study Completion: 2017-07-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

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