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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014661
Receipt No. R000017050
Scientific Title Phase II study of dose-escalation of Regorafenib for patients with previously treated metastatic colorectal cancer.
Date of disclosure of the study information 2014/07/28
Last modified on 2016/02/04

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

Public contact
1st name of contact person
1st name
Middle name
Last name Ryuta Nishitai
Organization Kyoto-Katsura Hospital
Division name Department of Surgery
Zip code
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
Address
Tel
Email

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
2016 Year 02 Month 04 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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