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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016840 |
Receipt No. | R000019508 |
Scientific Title | Exploratory analyses of biomarker using change of blood free amino-acid concentration related to JPH203(LAT1 inhibitor). |
Date of disclosure of the study information | 2015/03/20 |
Last modified on | 2020/09/07 |
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 |
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Condition | |||||||
Condition | Solid tumors | ||||||
Classification by specialty |
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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.
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Key secondary outcomes | To reveal difference in various tumors of blood free amino-acid concentration in patients with solid tumors.
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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.
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Key exclusion criteria | Patients who refuse to supply the data. | |||
Target sample size | 21 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
jfuruse@ks.kyorin-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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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 |
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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 |
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Results Delayed | |||||||
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Date of the first journal publication of results | |||||||
Baseline Characteristics | |||||||
Participant flow | |||||||
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Outcome measures | |||||||
Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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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 |
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Last modified on |
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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 |