UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021999 |
|---|---|
| Receipt number | R000025350 |
| Scientific Title | Personalized therapy for pazopanib |
| Date of disclosure of the study information | 2016/04/20 |
| Last modified on | 2023/02/15 16:21:08 |
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Basic information
Public title
Personalized therapy for pazopanib
Acronym
Personalized therapy for pazopanib
Scientific Title
Personalized therapy for pazopanib
Scientific Title:Acronym
Personalized therapy for pazopanib
Region
| Japan |
Condition
Condition
Malignant soft tissue tumor
Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the pharmacokinetics, efficacy, and side effects of pazopanib in patients with malignant soft tissue tumor or renal cell carcinoma
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare blood concentration, efficy and adverse events of pazopanib
Key secondary outcomes
To evaluate factors that affect the blood concentration of pazopanib
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving pazopanib for malignant soft tissue tumor or renal cell carcinoma
Key exclusion criteria
No
Target sample size
20
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-city, Miyagi
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-city, Miyagi
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
Management expenses grants
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Patients who were admitted to our hospital urology, met the selection criteria on or after April 1, 2016
Management information
Registered date
| 2016 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025350
| 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 |
