Survey of Cabozantinib Used To Treat People With Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

Drug Use Surveillance for Cabometyx Tablets "Renal Cell Carcinoma"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04804813
• Other study ID #: Cabozantinib-5001
• Secondary ID: jRCT2031210003
• Status: Completed
• Start date: March 29, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a survey in Japan of Cabozantinib tablets used to treat people with a type of kidney cancer called renal cell 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 renal cell carcinoma will take Cabozantinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Cabozantinib for 26 weeks.

Description:

The drug being tested in this study is called cabozantinib tablets. This tablet is being tested to treat people who have radically unresectable or metastatic renal cell carcinoma.

This study is an observational (non-interventional) study and will look at occurrence of adverse drug reactions (or adverse events) of cabozantinib tablets in the routine clinical setting. The planned number of observed patients will be approximately 300.

This multi-center observational trial will be conducted in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients with radically unresectable or metastatic renal cell carcinoma who do not meet the following exclusion criterion are eligible.

Exclusion Criteria:

A patient who has a history of hypersensitivity to any component of cabozantinib.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

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 26 weeks
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 26 weeks
Primary	Number of Participants with Adverse Events Leading to Permanent Treatment Discontinuation with Cabozantinib Tablets		Up to 26 weeks
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 26 weeks
Secondary	Percentage of Participants Who Achieve or Maintain Any Best Response Category	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 26 weeks

External Links

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