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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014661

Enrollment

Registered

2014-07-28

Start date

2014-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously treated metastatic colorectal cancer

Interventions

Regorafenib is administered orally once daily for 21 days followed by 7 days rest. The initial dose of regorafenib is 80mg/day, and dose-escalation to 120mg or 160mg/day should be considered every two

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histopathologically confirmed adenocarcinoma. 2. Patients with unresectable recurrent or advanced colorectal cancer. 3. Patients with previously fully-treated metastatic colorectal cancer. 4. Patients with any ECOG Performance Status. 5. Patients with sufficient function of important organs which should be confirmed within 7 days of the first regorafenib administration. 6. Patients with sufficient oral intake. 7. Patients 20 years or older. 8. Patients with written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Time to Treatment Failure	—

Secondary

Measure	Time frame
Response rate Desease control rate Overall survival Progression-free survival Frequency and grade of adverse event	—

Countries

Japan

Contacts

Public ContactRyuta Nishitai

Kyoto-Katsura Hospital Department of Surgery

rnishi@katsura.com075-391-5811

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026