UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of dose-escalation of Regorafenib for patients with previously treated metastatic colorectal cancer.
Acronym	DEREGULATE study
Scientific Title	Phase II study of dose-escalation of Regorafenib for patients with previously treated metastatic colorectal cancer.
Scientific Title:Acronym	DEREGULATE study
Region	Japan

Condition
Condition	Previously treated metastatic colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Phase II study of Dose-escalation of Regorafenib for patients with previously treated metastatic colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Time to Treatment Failure
Key secondary outcomes	Response rate Desease control rate Overall survival Progression-free survival Frequency and grade of adverse event

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Dai Middle name Last name Manaka
Organization	Kyoto-Katsura Hospital
Division name	Department of Surgery
Zip code	6158256
Address	17, Yamada-Hirao, Nishikyo, Kyoto-city, 615-8256, Kyoto, Japan
TEL	075-391-5811
Email	d_manaka@katsura.com

Public contact
Name of contact person	1st name Ryuta Middle name Last name Nishitai
Organization	Kyoto-Katsura Hospital
Division name	Department of Surgery
Zip code	6158256
Address	17, Yamada-Hirao, Nishikyo, Kyoto-city, 615-8256, Kyoto, Japan
TEL	075-391-5811
Homepage URL
Email	rnishi@katsura.com

Sponsor
Institute	Kyoto-Katsura Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto-Katsura Hospital
Address	17 Yamada-Hirao, Nishikyo, Kyoto
Tel	+81-75-391-5811
Email	noriko.fujita@katsura.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	社会福祉法人京都社会事業財団京都桂病院（京都府） 滋賀県立成人病センター（滋賀県） 亀岡市立病院（京都府）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date	2014 Year 07 Month 28 Day
Last follow-up date	2017 Year 07 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 07 Month 26 Day
Last modified on	2020 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017050