UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014661 |
|---|---|
| Receipt number | 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 | 2020/02/05 12:11:47 |
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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
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
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
rnishi@katsura.com
Sponsor or person
Institute
Kyoto-Katsura Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017050
