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

Not yet recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT07035886
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Start: 2025-11-30
• Primary Completion: 2029-09-01
• Study Completion: 2031-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Age greater than or equal to (≥)18 years.
• Participants who are treated 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall Survival (OS) Rate	Up to 6 months	OS will be defined as the time from the start date of Fruzaqla to the date of death from any cause. 6 months- OS rate is the percentage of participants who are alive for 6 months after their start date of Fruzaqla.
Progression Free Survival (PFS) Rate	Up to 6 months	PFS will be defined as the time from the start date of Fruzaqla to the date of documented progression or death from any cause. 6 months- PFS rate is the percentage of participants who have not experienced progression or death for 6 months after their start date of Fruzaqla.
Objective Response Rate (ORR)	Up to 12 treatment cycles (approximately 1 year)	ORR is defined as the percentage of participants achieving a best response of complete response (CR) or partial response (PR).
Disease Control Rate (DCR)	Up to 12 treatment cycles (approximately 1 year)	DCR is defined as the percentage of participants achieving a best response of CR, PR, or Stable Disease (SD).
Median Overall Survival (mOS)	Up to 12 treatment cycles (approximately 1 year)	mOS will be defined as the median 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.
Median Progression Free Survival (mPFS)	Up to 12 treatment cycles (approximately 1 year)	mPFS will be defined as the median time from the start date of Fruzaqla to the date of documented progression or death from any cause. The mPFS is the time at which 50% of participants are expected to have experienced disease progression or died from any cause.