Colorectal CancerNCT07035886
A Study to Monitor the Fruzaqla Treatment of Adults With Metastatic Colorectal Cancer (mCRC) in South Korea
An observational study of Colorectal Cancer, run by Takeda at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Sep 2025to 1 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Hospital
Seoul, 03722
Site Contact, 82-10-3356-7610, BEOMSH@yuhs.ac
Beom Seung-Hoon
About this study
Official title: 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.
- Conditions
- Colorectal Cancer
- Being tested
- No intervention
- Keywords
- Fruzaqla, Fruquintinib, Non-interventional
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
As this is an observational study, no intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs
Measured: 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
Measured: Up to approximately 6 years
Number of Participants with AEs with Grade 3 or Higher
Measured: Up to approximately 6 years
Number of Participants who Reported the Events Related to Important Risks in the Risk Management Plan (RMP)
Measured: Up to approximately 6 years
Secondary outcomes (6)
Overall Survival (OS) Rate
OS rate is the percentage of participants who are alive for 6 months after their start date of Fruzaqla capsule.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 18 treatment cycles (approximately up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start29 Sep 2025
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035886
- Sponsor's protocol ID
- TAK-113-4001
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance (Usage Results Study) of Fruzaqla Capsule (Fruquintinib) for the Approved Indications in South Korea
- ClinicalTrials.gov ID
- NCT07035886
- Acronym / sponsor ID
- TAK-113-4001
- Conditions
- Colorectal Cancer
- Keywords
- Fruzaqla, Fruquintinib, Non-interventional
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | – | Other: No interventionData 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAs this is an observational study, no intervention will be administered. | Other | All Study Participants |
Primary outcome
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
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- To obtain more information on the study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Takeda at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.