UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory analyses of biomarker using change of blood free amino-acid concentration related to JPH203(LAT1 inhibitor).
Acronym	Exploratory analyses of biomarker using change of blood free amino-acid concentration related to JPH203(LAT1 inhibitor).
Scientific Title	Exploratory analyses of biomarker using change of blood free amino-acid concentration related to JPH203(LAT1 inhibitor).
Scientific Title:Acronym	Exploratory analyses of biomarker using change of blood free amino-acid concentration related to JPH203(LAT1 inhibitor).
Region	Japan

Condition
Condition	Solid tumors
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery Breast surgery Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Exploratory research on change of blood free amino-acid concentration related to JPH203, and reveal biomarker related to efficacy of JPH203.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Identification of biomarker related to efficacy of JPH203.
Key secondary outcomes	To reveal difference in various tumors of blood free amino-acid concentration in patients with solid tumors.

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 who are registered in JPH203-SBECD-PI study (UMIN000016546) and getting the informed consent from the patient.
Key exclusion criteria	Patients who refuse to supply the data.
Target sample size	21

Research contact person
Name of lead principal investigator	1st name Middle name Last name Junji Furuse
Organization	School of Medicine, Kyorin University
Division name	Department of Internal Medicine, Medical Oncology
Zip code
Address	6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL	0422-47-5511
Email	jfuruse@ks.kyorin-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Naohiro Okano
Organization	School of Medicine, Kyorin University
Division name	Department of Internal Medicine, Medical Oncology
Zip code
Address	6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL	0422-47-5511
Homepage URL
Email	naohiro-okano@ks.kyorin-u.ac.jp

Sponsor
Institute	School of Medicine, Kyorin University
Institute
Department

Funding Source
Organization	School of Medicine, Kyorin University
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
Address
Tel
Email

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	2015 Year 03 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://iv.iiarjournals.org/content/34/5/2595.long
Number of participants that the trial has enrolled	17
Results	The LAT1 inhibitor JPH203 showed promising activity against biliary tract cancer and high body mass index patients because of having sufficient gradients of LAT1-substarte plasma free amino acids, especially branched chain amino acids.
Results date posted	2020 Year 09 Month 07 Day
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	2015 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Analysis for identification of biomarker related to efficacy data from phase I clinical trial in patients with solid tumors (JPH203-SBECD-PI study).

Management information
Registered date	2015 Year 03 Month 19 Day
Last modified on	2020 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019508

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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