A Study to Monitor the Fruzaqla Treatment of Adults With Metastatic Colorectal Cancer (mCRC) in South Korea

NCT ID: NCT07035886

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-29

Study Completion Date

2031-03-01

Brief Summary

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The purpose of this study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) occurring with the use of fruquintinib among adult participants who have been administered fruquintinib as per the approved indications.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Study Participants

Data will be collected for participants with metastatic colorectal cancer (mCRC) who will receive Fruzaqla according to the approved indication as per the Physician's routine schedule.

No intervention

Intervention Type OTHER

As this is an observational study, no intervention will be administered.

Interventions

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No intervention

As this is an observational study, no intervention will be administered.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to (\>=)18 years.
* Participants who are initiate treatment or will be treated with Fruzaqla according to the approved label of South Korea.
* Participant voluntarily consent to participate in the study.

Exclusion Criteria

* Participants for whom Fruzaqla is contraindicated or those with risks that should avoid starting Fruzaqla, as per the product label.
* Participants actively participating in other interventional clinical trial(s) on mCRC treatments.
* Pregnant or breastfeeding women.
Minimum Eligible Age

18 Years

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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Yonsei University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Takeda Contact

Role: CONTACT

+1-877-825-3327

Facility Contacts

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Site Contact

Role: primary

82-10-2658-6261

Related Links

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Other Identifiers

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TAK-113-4001

Identifier Type: -

Identifier Source: org_study_id

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