Metastatic Colorectal CancerNCT07623174
A Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland
An observational study of Metastatic Colorectal Cancer, run by Takeda at 10 sites in Poland.
Trial summary
Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 110 participants
- Where
- 10 sitesPoland
- Study dates
- 13 Aug 2026to 31 Mar 2028
- 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: Eligible adult participants (aged 18 years and older) with mCRC who initiate treatment with fruquintinib under the national drug program (DP) (reimbursement program).
Who may be able to join
- Adult participants (aged 18 years and older) with mCRC who are eligible for treatment with fruquintinib under the national drug program B.4 and will receive fruquintinib as third or subsequent line treatment after progression on or intolerance to trifluride/tipiracil.
- Participants who signed informed consent to participate in the study at the time of enrollment and prior to the fruquintinib treatment initiation.
- Participants for whom adequate medical records are available to support the data collection requirements.
Who cannot join
- 1. Participant currently participates or plans to participate in an interventional clinical trial.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Poland10 sites, 10 recruiting
- Recruiting
Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku, Oddzial Onkologii Klinicznej im. dr E. Pileckiej z pododdzialem Chemioterapii Dziennej
Bialystok, Podlaskie Voivodeship, 15-027
Site Contact, +48 604 988 923, ptokajuk@gmail.com
Piotr Tokajuk
- Not yet recruiting
Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy, Ambulatorium Chemoterapii
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Site Contact, +48 601 343 401, chmielowskae@co.bydgoszcz.pl
Ewa Chmielowska
- Not yet recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej
Gliwice, Slskie, 44-102
Site Contact, +48 501 097 313, wieslaw.bal@gliwice.nio.gov.pl
Wieslaw Bal
- Not yet recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Onkologii
Krakow, Lesser Poland Voivodeship, 31-501
Site Contact, +48 661 329 298, akostrzewska@su.krakow.pl
Anna Kostrzewska
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie, Klinika Chorob Metabolicznych i Immunoonkologii, Oddzial Onkologii Klinicznej
Lublin, Lublin Voivodeship, 20-400
Site Contact, +48 662 650 011, tciszewski@usk1.pl
Tomasz Ciszewski
- Not yet recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu, Klinika Onkologii, Odcinek Dzienny
Opole, Opole Voivodeship, 45-061
Site Contact, +48 502 313 767, barbara.s.radecka@gmail.com
Barbara Radecka
- Not yet recruiting
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej Curie, Oddzial Onkologii Klinicznej i Immunoonkologii z Pododdzialem Dziennym i Izb Przyjec
Poznan, Greater Poland Voivodeship, 61-866
Site Contact, +48 505 530 966, joanna.gazdulska@wco.pl
Joanna Gazdulska
- Recruiting
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu, Oddzial Onkologiczny z Pod. Dziennej Chemioterapii
Przemyśl, Podkarpackie Voivodeship, 37-700
Site Contact, +48 661 957 237, kkuc@wszp.pl
Kamil Kuc
- Not yet recruiting
Zachodniopomorskie Centrum Onkologii, Oddzial Onkologii Klinicznej
Szczecin, West Pomeranian Voivodeship, 71-730
Site Contact, +48 507 044 036, kk197@wp.pl
Katarzyna Hetman
- Not yet recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Onkologii i Radioterapii
Warsaw, Masovian Voivodeship, 02-034
Site Contact, +48 506 159 219, lucjan.wyrwicz@nio.gov.pl
Lucjan Wyrwicz
About this study
Official title: FRAMEWORK-CRC: Fruquintinib Real-World Outcomes in mCRC - A Prospective Study of One-Year Progression-Free Survival and Overall Survival in Polish Patients
Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life.
The main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth.
Read more
Other aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study.
The study will look at data already existing in the participants' medical charts.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- No intervention
- 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
No Intervention will be administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with mCRC | Adult participants with metastatic colorectal cancer (mCRC) who initiate treatment with fruquintinib under reimbursement program will be included. Participants will be observed for 12 months after treatment initiation, or until death. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS as assessed by the Investigator is defined as the time from the first dose of fruquintinib until the first disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death for any reason. Participants without disease progression will be censored at the time of the last assessment of disease status.
Measured: Up to 12 months
Secondary outcomes (1)
Overall Survival (OS)
OS is defined as the time from the first dose of fruquintinib until death for any reason within the 12-month observation period or up the 12-month observation period whichever comes first. Participants will be censored at the time of the last assessment of survival status or day 365, if later survival status assessment is available.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start13 Aug 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 110 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
- NCT07623174
- Sponsor's protocol ID
- TAK-113-4011
- Status last verified
- Sep 2026
- First submitted
- 29 May 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRAMEWORK-CRC: Fruquintinib Real-World Outcomes in mCRC - A Prospective Study of One-Year Progression-Free Survival and Overall Survival in Polish Patients
- ClinicalTrials.gov ID
- NCT07623174
- Acronym / sponsor ID
- TAK-113-4011
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Jun 2026 (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.
Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life.
The main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth.
Other aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study.
The study will look at data already existing in the participants' medical charts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with mCRC | – | Other: No interventionAdult participants with metastatic colorectal cancer (mCRC) who initiate treatment with fruquintinib under reimbursement program will be included. Participants will be observed for 12 months after treatment initiation, or until death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible adult participants (aged 18 years and older) with mCRC who initiate treatment with fruquintinib under the national drug program (DP) (reimbursement program).
Key inclusion criteria (3 listed)
- Adult participants (aged 18 years and older) with mCRC who are eligible for treatment with fruquintinib under the national drug program B.4 and will receive fruquintinib as third or subsequent line treatment after progression on or intolerance to trifluride/tipiracil.
- Participants who signed informed consent to participate in the study at the time of enrollment and prior to the fruquintinib treatment initiation.
- Participants for whom adequate medical records are available to support the data collection requirements.
Key exclusion criteria (1 listed)
- 1. Participant currently participates or plans to participate in an interventional clinical trial.
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 interventionNo Intervention will be administered in this study. | Other | Participants with mCRC |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to 12 months
PFS as assessed by the Investigator is defined as the time from the first dose of fruquintinib until the first disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death for any reason. Participants without disease progression will be censored at the time of the last assessment of disease status.
1 secondary outcome
Overall Survival (OS)
Time frame: Up to 12 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 22 Sep 2026.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Click here for more information about this trial in easy-to-understand language.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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CRC
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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Takeda at 10 sites in Poland.
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 1 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland. 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?
Progression Free Survival (PFS) (time frame: Up to 12 months). 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 22 Sep 2026.