UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008808 |
|---|---|
| Receipt number | R000010355 |
| Scientific Title | Exploratory study for biomarkers to predict efficacy and toxicity to Sorafenib in patients with advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2019/09/05 09:40:07 |
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Basic information
Public title
Exploratory study for biomarkers to predict efficacy and toxicity to Sorafenib in patients with advanced hepatocellular carcinoma
Acronym
Biomarker study of sorafenib
Scientific Title
Exploratory study for biomarkers to predict efficacy and toxicity to Sorafenib in patients with advanced hepatocellular carcinoma
Scientific Title:Acronym
Biomarker study of sorafenib
Region
| Japan |
Condition
Condition
Hepatocellulara carcinoma
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore biomarkers to predict efficacy and toxicity to Sorafenib in patients with advanced hepatocellular carcinoma
Basic objectives2
Others
Basic objectives -Others
To evaluate correlation between genome/protein/metabolites biomarker candidate and efficacy/incidence of adverse events
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate correlation between genome/protein/metabolites biomarker candidate and efficacy/incidence of adverse events
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are indicated for sorafenib as the treatment of advanced or recurrent hepatocellular carcinoma
2. Patients who have never used sorafenib before
3. Patients with adequate organ function (to be confirmed within 2 weeks before the start of study treatment)
a. Neutrophil count >1000
b. Platelets >50000
c. Hemoglobin >8.0
d. Total bilirubin <2.0 mg/dL
e. Serum aspartate aminotransferase, serum alanine aminotransferase <200 IU/L
4. Child-Pugh score <8
5. Patients who have given written informed consent
Key exclusion criteria
1. Ineligible for dynamic CT or MRI;
2. Patients with cerebral metastasis;
3. Pregnant and breastfeeding women or those who may possibly be pregnant;
4. Patients with uncontrollable hypertension (BP>170 mmHg under medication) or with thromboembolism, ischemic heart disease, unstable angina pectoris, heart failure, or cerebrovascular disorder;
5. Patients with moderate or severe renal dysfunction (Ccr < 30 mL/min) including those on dialysis;
6. Patients with esophageal varices that may cause bleeding (those who had gastrointestinal bleeding in the past month);
7. Patients under treatment with drugs affecting the activity of CYP3A4 or UGT1A9 (e.g., carbamazepine, rifampicin, St. John's wort, etc. ) or drugs that may affect the serum concentration of sorafenib;
8. Patients with diseases related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); or
9. Patients judged as ineligible by the investigator in charge for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kondo |
Organization
National Cancer Center Hospital
Division name
Internal medicine
Zip code
Address
5-1-1, Tsukiji, Chuo-ku
TEL
03-3542-2511
shkondo@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kondo |
Organization
National Cancer Center Hospital
Division name
Internal medicine
Zip code
Address
5-1-1, Tsukiji, Chuoku, Tokyo
TEL
03-3542-2511
Homepage URL
shkondo@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Health Sciences
Name of secondary funder(s)
Bayer Yakuhin Ltd.
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
国立がん研究センター東病院
国立国際医療研究センター病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30062555
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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate correlation between genome/protein/metabolites biomarker candidate and efficacy/incidence of adverse events
Management information
Registered date
| 2012 | Year | 08 | Month | 30 | Day |
Last modified on
| 2019 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010355
