UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034034 |
|---|---|
| Receipt number | R000038797 |
| Scientific Title | Personalized therapy for pazopanib by pharmacokinetic analysis in patients with renal cell carcinoma or malignant soft tissue tumor |
| Date of disclosure of the study information | 2018/09/05 |
| Last modified on | 2024/03/11 12:14:58 |
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Basic information
Public title
Personalized therapy for pazopanib by pharmacokinetic analysis in patients with renal cell carcinoma or malignant soft tissue tumor
Acronym
Personalized therapy for pazopanib by PK analysis
Scientific Title
Personalized therapy for pazopanib by pharmacokinetic analysis in patients with renal cell carcinoma or malignant soft tissue tumor
Scientific Title:Acronym
Personalized therapy for pazopanib by PK analysis
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Malignant soft tissue tumor
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the relationship between pharmacokinetics and clinical findings (side effects and efficacy) in patients with renal cell carcinoma or malignant soft tissue tumor undergoing of pazopanib therapy
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze blood concentrations of pazopanib showing side effects and efficacy
Key secondary outcomes
To examine 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
1)Patients receiving pazopanib for renal cell carcinoma or malignant soft tissue tumor
2)Witten informed concent from patients or proxies
Key exclusion criteria
1)History of hypersensitivity to pazopanib
2)Pregnant status
3)Lactation status
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Sato |
Organization
Tohoku Medical and Pharmaceutical University Faculty of Medicine
Division name
Department of urology
Zip code
983-8536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai-city, Miyagi
TEL
022-234-4181
ms.hifu@tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Ito |
Organization
Tohoku Medical and Pharmaceutical University Faculty of Medicine
Division name
Department of urology
Zip code
983-8536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai-city, Miyagi
TEL
022-234-4181
Homepage URL
itojun@tohoku-mpu.ac.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Clinical Research Promotion Center
Address
1-12-1 Fukumuro, Miyagino-ku, Sendai-city, Miyagi
Tel
022-259-1221
research@hosp.tohoku-mpu.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
| 2018 | Year | 09 | Month | 05 | 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
14
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
| 2018 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze the relationship between pharmacokinetics and clinical findings (side effects and efficacy) in patients with renal cell carcinoma or malignant soft tissue tumor undergoing of pazopanib therapy
Management information
Registered date
| 2018 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038797
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
