UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032400 |
|---|---|
| Receipt number | R000036953 |
| Scientific Title | Phase II study exploring reduction method of Lenvatinib for the patients with advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2018/04/26 |
| Last modified on | 2019/06/22 16:27:38 |
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Basic information
Public title
Phase II study exploring reduction method of Lenvatinib for the patients with advanced hepatocellular carcinoma
Acronym
Lenvatinib reduction study
Scientific Title
Phase II study exploring reduction method of Lenvatinib for the patients with advanced hepatocellular carcinoma
Scientific Title:Acronym
Lenvatinib reduction study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of lenvatinib once daily for 14 days of each 3-week cycle in advanced hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety, Relative dose intensity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lenvatinib 8mg once daily for 14 days of each 3-week cycle
Interventions/Control_2
Lenvatinib 4mg once daily
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
Clinically diagnosed as hepatocellular carcinoma; unsuitable for local therapy; receiving 8mg daily of Lenvatinib for 14 days or more; Child-Pugh score <=8; age >=20; ECOG Performance status <=2; preservation of major organ function; written informed consent
Key exclusion criteria
Refractory ascites or pleural effusion, history of hepatic encephalopathy, risky varices; double cancer; metastases to central nervous system; severe complication; pregnant or lactating women, or women of childbearing potential; mental disorder; allergy for Lenvatinib, or contrast agent of CT or/and MRI
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamashita |
Organization
Kanazawa University
Division name
Advanced Preventive Medical Sciences Research Center
Zip code
920-8641
Address
13-1, Takaramachi, Kanazawa
TEL
076-265-2235
ytatsuya@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Terashima |
Organization
Kanazawa University
Division name
Advanced Preventive Medical Sciences Research Center
Zip code
920-8641
Address
13-1, Takaramachi, Kanazawa
TEL
076-265-2235
Homepage URL
tera@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa 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
Certified Review Board, Kanazawa University
Address
13-1, Takaramachi, Kanazawa
Tel
076-265-2048
crc.irb-knz@esct.jp
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 | 04 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 26 | Day |
Last modified on
| 2019 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036953
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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