N/A
Completed N=388
Survey of Cabozantinib Used To Treat People With Renal Cell Carcinoma
Source: ClinicalTrials.gov NCT04804813 ↗Enrolled (actual)
388
Serious AEs
26.2%
Results posted
Apr 2025
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) — 216; 46; 73; 28 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) |
216; 46; 73; 28 | — |
| PRIMARY Number of Participants With Grade 3 or Higher Adverse Events |
103; 29 | — |
| PRIMARY Percentage of Adverse Events Leading to Dose Changes of Cabozantinib |
72.0; 64.1 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions |
193; 41; 49; 18 | — |
| PRIMARY Number of Participants With Grade 3 or Higher Adverse Drug Reactions |
80; 24 | — |
| PRIMARY Percentage of Adverse Drug Reactions Leading to Dose Changes of Cabozantinib |
72.1; 74.3 | — |
| PRIMARY Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction |
52; 16; 2; 4 | — |
| PRIMARY Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction |
8; 7 | — |
| PRIMARY Percentage of Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction Leading to Dose Changes of Cabozantinib |
77.0; 78.9 | — |
| PRIMARY Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis |
9; 3; 4; 1 | — |
| PRIMARY Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Pancreatitis |
2; 3 | — |
| PRIMARY Percentage of Adverse Drug Reactions of Pancreatitis Leading to Dose Changes of Cabozantinib |
50.0; 100.0 | — |
| SECONDARY Percentage of Participants Who Achieve or Maintain Any Best Response |
106; 26 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04804813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.