A Study to Monitor the Fruzaqla Treatment of Adults With Metastatic Colorectal Cancer (mCRC) in South Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-Marketing Surveillance (Usage Results Study) of Fruzaqla Capsule (Fruquintinib) for the Approved Indications in South Korea
Overview
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.
Interventions
- Other No intervention
As this is an observational study, no intervention will be administered.
Primary outcome measures
- Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs [Time frame: 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 [Time frame: Up to approximately 6 years]
- Number of Participants with AEs with Grade 3 or Higher [Time frame: Up to approximately 6 years]
- Number of Participants who Reported the Events Related to Important Risks in the Risk Management Plan (RMP) [Time frame: Up to approximately 6 years]
Secondary outcome measures (6)
- Overall Survival (OS) Rate [Time frame: Up to 6 months]
- Progression Free Survival (PFS) Rate [Time frame: Up to 6 months]
- Objective Response Rate (ORR) [Time frame: Up to 18 treatment cycles (approximately up to 18 months)]
- Disease Control Rate (DCR) [Time frame: Up to 18 treatment cycles (approximately up to 18 months)]
- Median Overall Survival (mOS) [Time frame: Up to 18 treatment cycles (approximately up to 18 months)]
- Median Progression Free Survival (mPFS) [Time frame: Up to 18 treatment cycles (approximately up to 18 months)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Yonsei University Hospital — Seoul
Identifiers
NCT: NCT07035886 · TAK-113-4001