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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033300
Receipt No. R000037556
Official scientific title of the study Impact of gene polymorphism on the pharmacokinetics and the clinical response in patients with hepatocellular carcinoma using lenvatinib
Date of disclosure of the study information 2018/07/05
Last modified on 2018/07/05

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Basic information
Official scientific title of the study Impact of gene polymorphism on the pharmacokinetics and the clinical response in patients with hepatocellular carcinoma using lenvatinib
Title of the study (Brief title) 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 To clarify the relationship between the exposure of lenvatinib and the clinical response

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 Hironao Okubo
Organization Juntendo University Nerima Hospital
Division name Department of Gastroenterology
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 Hironao Okubo
Organization Juntendo University Nerima Hospital
Division name Department of Gastroenterology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 16 Day
Anticipated trial start date
2018 Year 07 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information none (preinitiation)

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


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

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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