UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033300 |
|---|---|
| Receipt number | R000037556 |
| Scientific Title | 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 | 2022/07/08 09:54:24 |
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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
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
drokubo@juntendo-nerima.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037556
