Survey of Cabozantinib Used To Treat People With Renal Cell Carcinoma

NCT ID: NCT04804813

Last Updated: 2025-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

388 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-29

Study Completion Date

2024-07-25

Brief Summary

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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

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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.

Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cabozantinib 60 mg

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

Cabozantinib

Intervention Type DRUG

Cabozantinib tablets

Interventions

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Cabozantinib

Cabozantinib tablets

Intervention Type DRUG

Other Intervention Names

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Cabometyx tablets

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Takeda Selected Site

Tokyo, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://clinicaltrials.takeda.com/study-detail/606d5f0c620b3b001e9dbb51

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

Other Identifiers

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jRCT2031210003

Identifier Type: REGISTRY

Identifier Source: secondary_id

Cabozantinib-5001

Identifier Type: -

Identifier Source: org_study_id

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