UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043775 |
|---|---|
| Receipt number | R000049970 |
| Scientific Title | Impact of pharmacokinetics of Cabozantinib on clinical response and adverse event in patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2021/03/29 |
| Last modified on | 2021/03/29 11:11:26 |
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Basic information
Public title
Impact of pharmacokinetics of Cabozantinib on clinical response and adverse event in patients with hepatocellular carcinoma
Acronym
Pharmacokinetics and clinical effect of Cabozantinib
Scientific Title
Impact of pharmacokinetics of Cabozantinib on clinical response and adverse event in patients with hepatocellular carcinoma
Scientific Title:Acronym
Pharmacokinetics and clinical effect of Cabozantinib
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 impact of pharmacokinetics of Cabozantinib on clinical response and adverse event in patients with 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 cabozantinib and the clinical response during the treatment.
Key secondary outcomes
To clarify the relationship between the exposure of cabozantinib and the development of adverse events during the treatment.
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 or B
3. Refractory to systemic chemotherapy to the hepatocellular carcinoma.
Key exclusion criteria
Patients regarded as inappropriate subject
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hironao |
| Middle name | |
| Last name | Okubo |
Organization
Juntendo University Nerima Hospital
Division name
Gastroenterology
Zip code
1778521
Address
3-1-10 Takanodai, Nerima-ku Tokyo, Japan
TEL
0359233111
drokubo@juntendo-nerima.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Katsuki |
Organization
Juntendo University Nerima Hospital
Division name
GCP center
Zip code
1778521
Address
3-1-10 Takanodai, Nerima-ku Tokyo, Japan
TEL
0359233111
Homepage URL
gcp@juntendo-nerima.jp
Sponsor or person
Institute
Juntendo University
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
Juntendo University Nerima Hospital, GCP center
Address
3-1-10 Takanodai, Nerima-ku Tokyo, Japan
Tel
0359233111
gcp@juntendo-nerima.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
| 2021 | Year | 03 | Month | 29 | 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
| 2021 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study to examine plasma trough concentration of cabozantinib
Management information
Registered date
| 2021 | Year | 03 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049970
