UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008529 |
|---|---|
| Receipt number | R000010017 |
| Scientific Title | PhaseI/ II study of disulfiram in patients with advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2012/07/27 |
| Last modified on | 2012/08/01 19:32:26 |
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Basic information
Public title
PhaseI/ II study of disulfiram in patients with advanced hepatocellular carcinoma
Acronym
Phase I/II study of disulfiram in patients with advanced hepatocellular carcinoma
Scientific Title
PhaseI/ II study of disulfiram in patients with advanced hepatocellular carcinoma
Scientific Title:Acronym
Phase I/II study of disulfiram in patients with advanced hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the recommended dose of dosulfiram and evaluate the efficacy and toxicity of disulfiram for advanced hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: Recommended Dose
Phase II: Overall survival
Key secondary outcomes
Phase II: Adverse events
Response rate
Progression free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) hepatocellular carcinoma confirmed histologically or clinically (typical diagnostic images and over the upperlimit of AFP)
2) No indication for surgical resection, liver transplantation, local ablation therapy or transarterial chemoembolization
3) aged 20-79 years old
4) measurable or assessable lesion(s)
5) ECOG Performance Status 0-2
6) Adequate organ function
a) Neutrophil>=1000 /mm3
b) Hb>= 8.0 g/dL
c) PLT>= 50000 /mm3
d) T-Bil<= 3.0 mg/dL
e) Albumin>= 2.8 g/dL
f) AST<= 150 IU/L
g) ALT<= 150 IU/L
h) Amylase<= 300 U/L
i) Cre<= 1.5 mg/dl
7) Child-Pugh score 5-8 points
8) Interval of at least 4 weeks between last treatment and start of present chemotherapy regimen
9) No prior systemic chemotherapy
10) Written informed consent
11) Life expectancy of at least 8 weeks
12) sorafenib refractory hepatocellular carcinoma
Key exclusion criteria
1)Massive pleural or abdominal effusion
2)Uncontrolled hypertension
3)Uncontrolled heart disease
4)Evidence of Myocardial infarction witin 6 months
5)Active infection (except viral hepatitis)
6)Active gastrointestinal bleeding or ulcer
7)active double cancer
8)encephalopacy or severe mental disorder
9)severe drug allergy
10)pregnancy or lactaing females
11)inadequate for administration orally
12)Inadequate physical condition,as diagnosed by primary physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Yokosuka |
Organization
Chiba University Hospital
Division name
Depatrment of gastroenterology
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba, Jaoan
TEL
043-222-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Nakagawa |
Organization
Chiba University Hospital
Division name
Depatrment of gastroenterology
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba Japan
TEL
Homepage URL
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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
千葉大学付属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 27 | 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
| 2012 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 25 | Day |
Last modified on
| 2012 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010017
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