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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040923
Receipt No. 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

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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
Email 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
Email yoshiy@yamaguchi-u.ac.jp

Sponsor
Institute Department of Urology, Graduate School of Medicine, Yamaguchi University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046729

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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