UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017365 |
|---|---|
| Receipt number | R000020154 |
| Scientific Title | The study for personnlized medicine using sorafenib with genome analysis |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2015/05/01 10:49:19 |
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Basic information
Public title
The study for personnlized medicine using sorafenib with genome analysis
Acronym
The study of sorafenib
Scientific Title
The study for personnlized medicine using sorafenib with genome analysis
Scientific Title:Acronym
The study of sorafenib
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma and renal cell carcinoma taking sorafenib
Classification by specialty
| Gastroenterology | Nephrology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Sorafenib is the oral molecular target drug addaptation to unresectable or metastatic renal cell carcinoma and hepatocellular carcinoma. Hand food syndrome and hypertension were shown as the side effect dosing sorafenib and liver failure and hepatic encephalopathy are detected in rare cases. However the correlation between the side effects and the pharmacokinetics of sorafenib is not obvious. So we aimed the elucidation of the mechanism of the expression of the side effect dosing sorafenib and search of the parameter for evoid the side effect. The individual difference of pharmacokinetics of sorafenib were suggested for the variant with ADME. So, we tried to analysis the genetic polymorphism of nuclear receptors, tranporters, drug-metabolizing enzymes, and the concentration of serum component. In addition, we aimed the analysis of the correlation of the results of them and the side effects and therapeutic effects.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Gene (PXR,ABCG1, ABCG2,CYP3A4,CYP3A5)
The serum concentration of sorafenib and the metabolites
The serum components
Key secondary outcomes
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
The patients with hepatocellular carcinoma and renal cell carcinoma taking sorafenib
Key exclusion criteria
No
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nariyasu Mano |
Organization
Tohoku university hospital
Division name
Department of Pharmaceutical Sciences
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7525
mano@hosp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Yamaguchi |
Organization
Tohoku university hospital
Division name
Department of Pharmaceutical Sciences
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7528
Homepage URL
yamaguchi@hosp.tohoku.ac.jp
Sponsor or person
Institute
Department of Pharmaceutical sciences, Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
Donation, Grant-in-Aid, Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of gastroenterology, Tohoku university hospital
Department of urology, Tohoku university hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The concentration of sorafenib and the metabolites in the serum of the subject patients and the pharmacokinetics parameters are being analyzing.
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2015 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020154
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
