UMIN-CTR Clinical Trial

Basic information
Public title	Impact of gene polymorphism on the pharmacokinetics and the clinical response in patients with hepatocellular carcinoma using lenvatinib
Acronym	Gene polymorphism and the pharmacokinetics and clinical response of lenvanib
Scientific Title	Impact of gene polymorphism on the pharmacokinetics and the clinical response in patients with hepatocellular carcinoma using lenvatinib
Scientific Title:Acronym	Gene polymorphism and the pharmacokinetics and clinical response of lenvanib
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the impact of genetic polymorphisms on the pharmacokinetics of lenvatinib in patients with advanced hepatocellular carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify the relationship between the exposure of lenvatinib at the start of treatment and two week from the start of treatment and the gene polymorphisms of p-glycoprotein and breast cancer resistant protein.
Key secondary outcomes	1)To clarify the relationship between the exposure of lenvatinib and the clinical response 2)To examine relationship between plasma and urinary carnitine levels and extent of fatigue

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	1. Performance Status 0 or 1 (ECOG) 2. Child-Pugh class A (score 5 or 6) 3. No past history of molecular targeting drugs including treatment of the other cancers. 4. Laboratory data fulfills all criteria as below 1) neutrophil count more than 1.5x109 /L 2) Hemogblobin more than 8.5 g/dL 3) Total bilirubin less than 2.0 mg/dL 4) Blood pressure less than 150/90 mmHg
Key exclusion criteria	1. Patients regarded as inappropriate subject 2. Patients who lack of ability of judgement, despite fulfill the listed above
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hironao Okubo
Organization	Juntendo University Nerima Hospital
Division name	Department of Gastroenterology
Zip code
Address	3-1-10 Takanodai, Nerima-Ku Tokyo, Japan
TEL	+81-3-5923-3111
Email	drokubo@juntendo-nerima.jp

Public contact
Name of contact person	1st name Middle name Last name Hironao Okubo
Organization	Juntendo University Nerima Hospital
Division name	Department of Gastroenterology
Zip code
Address	3-1-10 Takanodai, Nerima-Ku Tokyo, Japan
TEL	+81-3-5923-3111
Homepage URL
Email	drokubo@juntendo-nerima.jp

Sponsor
Institute	Juntendo University Nerima Hospital
Institute
Department

Funding Source
Organization	Self funding
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	2018 Year 07 Month 05 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	Terminated
Date of protocol fixation	2018 Year 05 Month 16 Day
Date of IRB	2018 Year 07 Month 03 Day
Anticipated trial start date	2018 Year 07 Month 06 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none (preinitiation)

Management information
Registered date	2018 Year 07 Month 05 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037556