UMIN-CTR Clinical Trial

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