Survey of Cabozantinib Tablets Used To Treat People With Hepatocellular Carcinoma

Hepatocellular Cancer Clinical Trial

Official title:

Special Drug Use Surveillance for Cabometyx Tablets "Hepatocellular Carcinoma"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100082
• Other study ID #: Cabozantinib-5002
• Secondary ID: jRCT2031210403
• Status: Recruiting
• Start date: November 17, 2021
• Est. completion date: November 30, 2025

Study information

• Verified date: December 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a survey in Japan of Cabozantinib tablets used to treat Japanese people with a type of liver cancer called hepatocellular carcinoma. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects from Cabozantinib. During the study, participants with hepatocellular carcinoma will take Cabozantinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Cabozantinib for 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Participants with unresectable hepatocellular carcinoma that has progressed after cancer chemotherapy (Regardless of previous treatment history) Exclusion Criteria: Participants who has a history of hypersensitivity to any component of cabozantinib.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Cancer
• Liver Neoplasms

Intervention

Drug:
• Cabozantinib
Cabozantinib tablets

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events Related to Hepatic Failure, Hepatic Dysfunction, and Pancreatitis	An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	Up to 12 months
Primary	Number of Participants with Serious Adverse Events	A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.	Up to 12 months
Primary	Number of Participants with Adverse Events Leading to Permanent Treatment Discontinuation with Cabozantinib Tablets		Up to 12 months
Primary	Number of Participants with Grade 3 or higher Adverse Events	Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	Up to 12 months
Secondary	Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	Best response will be assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best response is defined as the level of best response in assessment with complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) and not evaluable (NE) during the observational period.	Up to 12 months
Secondary	Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST)	Best response will be assessed with reference to the excerpts from Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST). Best response is defined as the level of best response in assessment with CR, PR, PD, SD and NE during the observational period.	Up to 12 months
Secondary	Disease Control Rate (DCR)	DCR was defined as the percentage of participants whose best overall response is CR, PR or SD, per RECIST 1.1. CR was defined as disappearance of all target lesions; PR was defined as at least a 30% decrease in the sum of diameter (SoD) of target lesions, taking as a reference the baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.	Up to 12 months
Secondary	Overall Survival (OS)	OS is defined as time from the first day of study drug administration to death due to any cause.	Up to 12 months

External Links

•   To obtain more information on the study, click here/on this link.