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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• South Korea
  • Seoul, South Korea, 03722
    • Recruiting
    • Yonsei University Hospital
    • Principal Investigator: Beom Seung-Hoon
    • Contact: Site Contact; Phone Number: 82-10-3356-7610; Email: BEOMSH@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with mCRC in South Korea who initiate the first treatment with Fruzaqla according to the approved indication will be included in this study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention; As this is an observational study, no intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Rate	OS rate is the percentage of participants who are alive for 6 months after their start date of Fruzaqla capsule.	Up to 6 months
Progression Free Survival (PFS) Rate	PFS rate is the percentage of participants who have not experienced progression or death for 6 months after their start date of Fruzaqla capsule.	Up to 6 months
Objective Response Rate (ORR)	ORR is defined as the percentage of participants achieving a best response of complete response (CR) or partial response (PR).	Up to 18 treatment cycles (approximately up to 18 months)
Disease Control Rate (DCR)	DCR is defined as the percentage of participants achieving a best response of CR, PR, or Stable Disease (SD).	Up to 18 treatment cycles (approximately up to 18 months)
Median Overall Survival (mOS)	OS will be defined as the time from the start date of Fruzaqla to the date of death from any cause. The mOS is the time at which 50% of participants are expected to have died from any cause.	Up to 18 treatment cycles (approximately up to 18 months)
Median Progression Free Survival (mPFS)	PFS will be defined as the time from the start date of Fruzaqla capsule to the date of documented progression or death from any cause. Tumor assessment will be performed by routine clinical practice of the investigators. The mPFS is the time at which 50% of participants are expected to have experienced disease progression or died from any cause.	Up to 18 treatment cycles (approximately up to 18 months)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click this link.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: June 17, 2025
• First Submitted That Met QC Criteria: June 17, 2025
• First Posted (Actual): June 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Non-interventional; Fruquintinib; Fruzaqla
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: TAK-113-4001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR