Clinical trial NCT04804813: Survey of Cabozantinib Used To Treat People With Renal Cell Carcinoma
Official title: Drug Use Surveillance for Cabometyx Tablets "Renal Cell Carcinoma"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 388
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with radically unresectable or metastatic renal cell carcinoma as part of routine medical care

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)
timeFrame: Up to 26 weeks
measure: Number of Participants With Grade 3 or Higher Adverse Events
timeFrame: Up to 26 weeks
measure: Percentage of Adverse Events Leading to Dose Changes of Cabozantinib
timeFrame: Up to 26 weeks
measure: Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
timeFrame: Up to 26 weeks
measure: Number of Participants With Grade 3 or Higher Adverse Drug Reactions
timeFrame: Up to 26 weeks
measure: Percentage of Adverse Drug Reactions Leading to Dose Changes of Cabozantinib
timeFrame: Up to 26 weeks
measure: Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction
timeFrame: Up to 26 weeks
measure: Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction
timeFrame: Up to 26 weeks
measure: Percentage of Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction Leading to Dose Changes of Cabozantinib
timeFrame: Up to 26 weeks
measure: Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis
timeFrame: Up to 26 weeks
measure: Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Pancreatitis
timeFrame: Up to 26 weeks
measure: Percentage of Adverse Drug Reactions of Pancreatitis Leading to Dose Changes of Cabozantinib
timeFrame: Up to 26 weeks
Secondary outcomes:
measure: Percentage of Participants Who Achieve or Maintain Any Best Response
timeFrame: Up to 26 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: