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

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 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

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

Value
https://center6.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