UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043378 |
|---|---|
| Receipt number | R000049529 |
| Scientific Title | Usefulness of monitoring sunitinib plasma concentration for the patients with metastatic renal cell carcinoma |
| Date of disclosure of the study information | 2021/02/19 |
| Last modified on | 2021/02/19 14:32:36 |
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Basic information
Public title
Usefulness of monitoring sunitinib plasma concentration for the patients with metastatic renal cell carcinoma
Acronym
Monitoring for plasma concentration of sunitinib
Scientific Title
Usefulness of monitoring sunitinib plasma concentration for the patients with metastatic renal cell carcinoma
Scientific Title:Acronym
Monitoring for plasma concentration of sunitinib
Region
| Japan |
Condition
Condition
metastatic renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To monitor sunitinib plasma concentration in order to bring out maximum treatment effect for the patients with metastatic renal cell carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
sunitinib plasma concentration
Key secondary outcomes
progression free survival periods, rate of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Periods: to finish of sunitinib treatment
Amount: standard
Interventions/Control_2
Periods: to finish of sunitinib treatment
Amount: alternative
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Patients with metastatic renal cell carcinoma who have measurable regions
2 Patients who are scheduled sunitinib treatment
Key exclusion criteria
1 with liver and/or renal dysfunction (over ULNx2)
2 with severe heart failure
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kojiro |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University Hospital
Division name
Department of Urology and Renal Transplantation
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki, Japan
TEL
+81958197340
ohba-k@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University Hospital
Division name
Department of Urology and Renal Transplantation
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki, Japan
TEL
+81958197340
Homepage URL
ohba-k@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
Sakamoto 1-7-1, Nagasaki, Japan
Tel
+81958197340
ohba-k@nagasaki-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
| 2021 | Year | 02 | Month | 19 | 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
64
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
Main results already published
Date of protocol fixation
| 2013 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 19 | Day |
Last modified on
| 2021 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049529
