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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04804813
Other study ID # Cabozantinib-5001
Secondary ID jRCT2031210003
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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