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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014566
Receipt No. R000016948
Scientific Title A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Date of disclosure of the study information 2014/07/16
Last modified on 2018/02/13

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Basic information
Public title A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Acronym A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Scientific Title A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Scientific Title:Acronym A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to progression after randomization
Key secondary outcomes Overall Survival
Overall survival after randomization; OS after randomization
Time to progression
Drug concentration of sorafenib
Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dose re-escalation of sorafenib from reduce dose
Interventions/Control_2 Continued sorafenib with reduce dose
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) 20 years or more
2) Presence of histologically confirmed or clinically diagnosed hepatocellular carcinoma
3) Absence of benefit from a treatment of established efficacy, such as resection, local ablation, and transarterial chemoembolization
4) Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1
5) Presence of Child-Pugh score 7 or less
Key exclusion criteria 1) History of a primary tumor diagnosed in the past 3 years
2) Presence of active bacterial infections, HIV/AIDS, or other diseases that would preclude study participation
3) Presence of uncontrolled or significant cardiovascular disease
4) Regular phenytoin or warfarin use
5) Presence of mental incapacity or psychiatric illness.
Target sample size 250

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Osamu Yokosuka
Organization Chiba university hospital
Division name Department of Gastroenterology
Zip code
Address 1-8-1 Inohana Chuo-ku Chiba
TEL 043-222-7171
Email yokosukao@faculty.chiba-u.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Sadahisa Ogasawara
Organization Chiba university hospital
Division name Department of Gastroenterology
Zip code
Address 1-8-1 Inohana Chuo-ku Chiba
TEL 043-222-7171
Homepage URL
Email sadahisa@me.com

Sponsor
Institute Chiba university hospital
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 07 Month 16 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 No longer recruiting
Date of protocol fixation
2014 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 15 Day
Last modified on
2018 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016948

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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