UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015404 |
|---|---|
| Receipt number | R000017914 |
| Scientific Title | The prospective study of the clinical efficacy/adverse event of regorafenib in unresectable metastatic and advanced colorectal cancer |
| Date of disclosure of the study information | 2014/10/10 |
| Last modified on | 2020/04/26 12:08:10 |
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Basic information
Public title
The prospective study of the clinical efficacy/adverse event of regorafenib in unresectable metastatic and advanced colorectal cancer
Acronym
Prediction of the Efficacy/Adverse event of Regorafenib in advanced Colorectal cancer (PEARC study)
Scientific Title
The prospective study of the clinical efficacy/adverse event of regorafenib in unresectable metastatic and advanced colorectal cancer
Scientific Title:Acronym
Prediction of the Efficacy/Adverse event of Regorafenib in advanced Colorectal cancer (PEARC study)
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the relationship between the blood concentration of regorafenib and the dosage amount, and to evaluate the association with clinical efficacy/adverse event and identify the potent polymorphisms and biomarkers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the association with clinical efficacy/adverse event of regorafenib
Key secondary outcomes
To explore the potent polymorphisms and biomarkers
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Unresectable metastatic and advanced colorectal cancer.
2. with sufficient organ function.
3. with written informed consent.
Key exclusion criteria
1. with potent drug affected activity of CYP3A4 or UGT1A9, and with potent drug affected blood concentration of regorafenib.
2. Pregnant female, possibly pregnant females and females feeding babies.
3. with uncontrollable hypertension (systolic >150 mmHg or diastolic >90 mmHg even with hypotensives)
4. with a history of embolism, ischemic heart disease, unstable angina, heart failure or cerebrovascular disease.
5. with severe allergy.
6. Any other patients whom the physician in charge of the study judges to be unsuitable.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shibata |
Organization
Akita University Hospital
Division name
Department of Clinical Oncology
Zip code
018-8543
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6261
hiroyuki@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shibata |
Organization
Akita University Hospital
Division name
Department of Clinical Oncology
Zip code
018-8543
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6262
Homepage URL
minoue@med.akita-u.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology, Akita University 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
Akita University
Address
Hondo 1-1-1, Akita, Japan
Tel
018-884-6262
hiroyuki@med.akita-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective exploratory study
Management information
Registered date
| 2014 | Year | 10 | Month | 10 | Day |
Last modified on
| 2020 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017914
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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