A Study to Monitor the Fruzaqla Treatment of Adults With Metastatic Colorectal Cancer (mCRC) in South Korea
Post-Marketing Surveillance (Usage Results Study) of Fruzaqla Capsule (Fruquintinib) for the Approved Indications in South Korea
1 other identifier
observational
600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedStudy Start
First participant enrolled
September 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
February 27, 2026
February 1, 2026
3.9 years
June 17, 2025
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs
Up to approximately 6 years
Number of Participants with Any Serious Adverse Events (SAEs), Serious Adverse Drug Reaction (SADRs), Expected and Unexpected SAEs and SADRs, AEs Leading to Death
Up to approximately 6 years
Number of Participants with AEs with Grade 3 or Higher
Up to approximately 6 years
Number of Participants who Reported the Events Related to Important Risks in the Risk Management Plan (RMP)
Up to approximately 6 years
Secondary Outcomes (6)
Overall Survival (OS) Rate
Up to 6 months
Progression Free Survival (PFS) Rate
Up to 6 months
Objective Response Rate (ORR)
Up to 18 treatment cycles (approximately up to 18 months)
Disease Control Rate (DCR)
Up to 18 treatment cycles (approximately up to 18 months)
Median Overall Survival (mOS)
Up to 18 treatment cycles (approximately up to 18 months)
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
As this is an observational study, no intervention will be administered.
Eligibility Criteria
Participants with mCRC in South Korea who initiate the first treatment with Fruzaqla according to the approved indication will be included in this study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Yonsei University Hospital
Seoul, 03722, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2025
First Posted
June 25, 2025
Study Start
September 29, 2025
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
March 1, 2031
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.