Monitoring Fruzaqla treatment in adults with metastatic colorectal cancer in South Korea
Post-Marketing Surveillance (Usage Results Study) of Fruzaqla Capsule (Fruquintinib) for the Approved Indications in South Korea
This project will track side effects, including serious ones, in adults in South Korea who are being treated with Fruzaqla (fruquintinib) for metastatic colorectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | fruquintinib |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07035886 on ClinicalTrials.gov |
What this trial studies
This observational, non-interventional study will enroll adults in South Korea who start or are receiving Fruzaqla for metastatic colorectal cancer and will collect adverse event data while patients are treated according to the approved label. Investigators at Yonsei University Hospital will record all adverse events and serious adverse events and estimate the proportion of patients experiencing these events. Key exclusions include patients with contraindications to Fruzaqla, pregnant or breastfeeding women, and those participating in other interventional mCRC trials. The study is sponsored by Takeda to provide postmarketing safety data specific to the Korean population.
Who should consider this trial
Good fit: Adults (≥18) in South Korea with metastatic colorectal cancer who are starting or receiving Fruzaqla according to the approved Korean label and can give informed consent.
Not a fit: Patients for whom Fruzaqla is contraindicated, pregnant or breastfeeding women, and those enrolled in other interventional mCRC trials are not expected to benefit from participation.
Why it matters
Potential benefit: If successful, the results could clarify Fruzaqla's safety profile in Korean mCRC patients and help clinicians better anticipate and manage side effects.
How similar studies have performed: Fruquintinib has shown efficacy in prior clinical trials and has been subject to postmarketing safety monitoring in other populations, so this study extends existing safety surveillance to Korean patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Yonsei University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.