Survey of Cabozantinib Used To Treat People With Renal Cell Carcinoma

Takeda

Status: Completed

Conditions: Renal Cell Carcinoma

Treatments: Drug: Cabozantinib

Study type: Observational

Funder types: Industry

Identifiers

NCT04804813

Cabozantinib-5001

jRCT2031210003 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 388 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

388 participants in 1 patient group

Cabozantinib 60 mg

Description:

Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks. Participants received interventions as part of routine medical care.

Treatment:

Drug: Cabozantinib