UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040923 |
|---|---|
| Receipt number | R000046729 |
| Scientific Title | The exploratory study to determine the optimal initial dose of tyrosine kinase inhibitors including combination immunotherapy in individual patients with advanced renal cell carcinoma |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2020/06/28 12:03:38 |
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Basic information
Public title
The exploratory study to determine the optimal initial dose of tyrosine kinase inhibitors including combination immunotherapy in individual patients with advanced renal cell carcinoma
Acronym
To determine the optimal initial dose of tyrosine kinase inhibitors including combination immunotherapy in renal cell carcinoma
Scientific Title
The exploratory study to determine the optimal initial dose of tyrosine kinase inhibitors including combination immunotherapy in individual patients with advanced renal cell carcinoma
Scientific Title:Acronym
To determine the optimal initial dose of tyrosine kinase inhibitors including combination immunotherapy in renal cell carcinoma
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to determine the optimal initial dose of tyrosine kinase inhibitors including combination immunotherapy in individual patients with advanced renal cell carcinoma using the pharmacokinetic data and gene polymorphism.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharmacokinetic data, gene polymorphism, clinical efficacy, adverse events
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with advanced renal cell carcinoma treated with axitinib or cabozantinib
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideyasu |
| Middle name | |
| Last name | Matsuyama |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Urology
Zip code
755-8505
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
0836-22-2275
hidde@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Yamamoto |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Urology
Zip code
755-8505
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
0836-22-2275
Homepage URL
yoshiy@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Urology, Graduate School of Medicine, Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Graduate School of Medicine, Yamaguchi University
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
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-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
| 2020 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 06 | Month | 28 | Day |
Last modified on
| 2020 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046729
