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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043775
Receipt No. 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

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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
Email 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
Email gcp@juntendo-nerima.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049970

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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