Colon CancerPhase 2FIRST-KNCT07510932
Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K)
A Phase 2 study testing Fruquintinib in people with Colon Cancer, run by Korea University Anam Hospital.
Trial summary
Background Patients with metastatic colorectal cancer who have progressed after treatment with oxaliplatin- and irinotecan-based chemotherapy, as well as anti-EGFR monoclonal antibodies (cetuximab or panitumumab) according to RAS mutation status, or anti-angiogenic agents (bevacizumab, ramucirumab, or aflibercept)… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Fruquintinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Sep 2027
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [Signed Written Informed Consent]
- Subjects who voluntarily provide signed written informed consent after receiving sufficient explanation of this clinical trial prior to initiation of any study-related procedures.
- [Age and Sex]
- Subjects aged 19 years or older at the time of signing the informed consent.
- For women of childbearing potential, a negative urine β-hCG pregnancy test within 14 days prior to the first administration of the investigational product (IP) is required.
- Women will be considered not of childbearing potential if they meet any of the following criteria; women who do not meet these criteria will be considered of childbearing potential.
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- Women older than 50 years of age who have experienced amenorrhea for at least 12 months after discontinuation of all exogenous hormonal treatments.
- Documented irreversible surgical sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
- (Tubal ligation is not permitted.)
- Women 50 years of age or younger who have experienced amenorrhea for at least 12 months after discontinuation of all exogenous hormonal treatments, and whose luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels fall within the postmenopausal range according to the institutional laboratory standards.
- Subjects with hCG-producing tumors may be enrolled at the discretion of the Principal Investigator.
- Subjects must agree to use effective contraception from the first administration of the investigational product until at least 4 weeks after the last administration.
- Female subjects of childbearing potential (or male subjects with female partners of childbearing potential) must use an effective method of contraception during the study treatment period and for at least 4 weeks after the last dose of the investigational product.
- Male subjects who have not undergone vasectomy (or female subjects with male partners) must use effective contraception during the study treatment period and for at least 4 weeks after the last dose, and must not donate sperm during this period.
- ※ Effective contraception methods include: Hormonal contraceptives (subdermal implants, injectable contraceptives, oral contraceptives, etc.), intrauterine devices (IUDs) or intrauterine hormone-releasing systems (IUSs), sterilization of the subject or partner (e.g., vasectomy or bilateral tubal ligation), or sexual abstinence, provided that abstinence is consistent with the subject's usual lifestyle.
- [Target Population]
- Metastatic colorectal cancer patients intolerant to second-line standard chemotherapy:
- Patients with histologically or cytologically confirmed metastatic or recurrent colorectal cancer who have received two prior systemic treatment regimens (first-line and second-line) including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
- Recurrence within 6 months after completion of adjuvant therapy will be considered as progression during first-line treatment.
- Subjects with an expected life expectancy of at least 3 months.
- ECOG performance status of 0 or 1.
- Evaluable disease according to RECIST version 1.1. (Measurable disease is not required.)
- Subjects must be able to swallow oral medications.
- [Clinical Laboratory Tests]
- Bone marrow function
- Hemoglobin (Hb) > 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L
- Platelet count (PLT) ≥ 75 × 10⁹/L
- Renal function
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance > 30 mL/min
- Hepatic function
- Total bilirubin ≤ 2.0 × ULN (In cases of biliary obstruction, the criteria must be met after appropriate biliary drainage.)
- AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases)
- Cardiac function
- QTc ≤ 480 msec
- If QTc exceeds 480 msec, QTc should be measured three consecutive times, and the subject may be enrolled if the average QTc value is < 480 msec.
Who cannot join
- [Interventional Treatments]
- Subjects who received an investigational product in another clinical trial within 14 days prior to the first administration of the investigational product in this study.
- Subjects who received cytotoxic chemotherapy within 14 days prior to the first administration of the investigational product, or monoclonal antibody therapy within 4 weeks prior to the first administration of the investigational product.
- Subjects who received radiotherapy involving more than 30% of the bone marrow within 4 weeks prior to the first administration of the investigational product, or palliative radiotherapy to a limited field within 2 weeks prior to the first administration.
- Subjects with persistent toxicities ≥ Grade 1 according to CTCAE from prior anticancer therapy that have not resolved before the first administration of the investigational product (except for alopecia).
- [Medical History and Concurrent Diseases]
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- Women who are pregnant or breastfeeding.
- Subjects with active, severe, or uncontrolled infection.
- Subjects with clinically significant cardiovascular disease, including but not limited to:
- Acute coronary syndrome within 6 months
- Congestive heart failure ≥ NYHA (New York Heart Association) Class II
- QTc prolongation or uncontrolled hypertension
- Other significant cardiovascular conditions (e.g., clinically significant arrhythmias or congenital long QT syndrome)
- Subjects with progressive brain metastases, defined as unstable or symptomatic brain lesions.
- Subjects whose lesions have been stable for at least 4 weeks following radiotherapy or surgery may be eligible for enrollment.
- (Leptomeningeal metastasis is excluded.)
- Subjects with active infections such as hepatitis B (HBV), hepatitis C (HCV), or HIV.
- However, enrollment is permitted under the following conditions:
- Subjects who are HBsAg positive may be enrolled if HBV DNA is below the lower limit of quantification according to local laboratory testing.
- Subjects with chronic HBV infection (HBsAg positive and HBV DNA positive) may be enrolled if they have received antiviral therapy for at least 3 months and are considered not to have active hepatitis at the investigator's discretion.
- Subjects with a history of previous HBV infection (IgG anti-HBc positive) may be enrolled if HBV DNA is below the lower limit of quantification.
- Subjects who are anti-HCV antibody positive may be enrolled if HCV RNA is below the lower limit of quantification.
- Subjects who underwent major surgery within 4 weeks prior to the first administration of the investigational product, or who have not adequately recovered from surgery.
- Subjects with a history of thrombosis within 6 months prior to the first administration of the investigational product.
- Subjects with a history or evidence of bleeding disorders.
- Subjects who are receiving high-dose anticoagulant therapy for therapeutic purposes.
- Subjects with non-healing wounds, active ulcers, or bone fractures.
- Subjects with a history of gastrointestinal perforation, active gastrointestinal bleeding, or abdominal fistula within the past 6 months.
- Subjects with proteinuria.
- If the urine dipstick test shows ≥2+ proteinuria, a 24-hour urine protein test or urine protein/creatinine ratio (UPCR) should be performed.
- Subjects will be excluded if:
- 24-hour urine protein > 1 g, or
- UPCR > 1.0
- Subjects with a history of surgery affecting drug absorption or with severe gastrointestinal disorders that may interfere with drug absorption.
- Subjects with a history of another primary malignancy, except for:
- Adequately treated non-melanoma skin cancer, or
- Stage I cancer that has shown no recurrence for at least 36 months after curative resection
- Subjects with known hypersensitivity to the active ingredient or excipients of the investigational product, including:
- Hypersensitivity or allergy to Allura Red (relevant to Fruquintinib capsule 5 mg)
- Hypersensitivity or allergy to Tartrazine (FD\&C Yellow No.5) or Sunset Yellow FCF (FD\&C Yellow No.6) (relevant to Fruquintinib capsule 1 mg)
- Subjects who are scheduled to undergo major surgery during the study period.
- Subjects who have medical, psychiatric, or cognitive conditions that may interfere with the understanding of study information, performance of study procedures, or provision of written informed consent.
- Subjects who are considered inappropriate for participation in the study at the discretion of the Principal Investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Background Patients with metastatic colorectal cancer who have progressed after treatment with oxaliplatin- and irinotecan-based chemotherapy, as well as anti-EGFR monoclonal antibodies (cetuximab or panitumumab) according to RAS mutation status, or anti-angiogenic agents (bevacizumab, ramucirumab, or aflibercept), have limited therapeutic options in the third-line setting. The phase III SUNLIGHT trial evaluating TAS-102 (trifluridine/tipiracil) in combination with bevacizumab demonstrated promising outcomes, with a median progression-free survival (PFS) of 5.6 months and a median overall survival (OS) of 10.8 months. However, approximately 30% of patients in that study had not previously received bevacizumab during first- or second-line treatment, indicating that a proportion of patients had not been fully exposed to current standard therapies for metastatic colorectal cancer. Therefore, there remains an unmet need to evaluate additional therapeutic strategies in patients who have received optimal prior standard treatments. This study aims to evaluate the efficacy and safety of fruquintinib as a third-line treatment in this population.
Hypothesis Proactive and comprehensive supportive care will not only help manage fruquintinib-related toxicities (e.g., hypertension, hand-foot syndrome, proteinuria, and fatigue), but also enable patients to maintain treatment, thereby potentially prolonging progression-free survival (PFS).
Study Design This is a multicenter, single-arm, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with supportive care in patients with metastatic colorectal cancer who are intolerant to second-line standard chemotherapy. All subjects will receive fruquintinib treatment in combination with supportive care. Supportive care refers to medical interventions aimed at preventing and managing adverse events associated with fruquintinib, including but not limited to hypertension, proteinuria, diarrhea, fatigue, and hand-foot syndrome.
- Conditions
- Colon Cancer
- Being tested
- Fruquintinib
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Fruquintinib
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib | Experimental | Not described Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: From initiation of IP drug to progression or death, up to 24 weeks
Secondary outcomes (3)
Overall survival
Measured: From initiation of IP drug to death, up to 2 years
Objective response rate
Measured: up to 24 weeks
Adverse events
Measured: every visit, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- one treatment arm
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee, Soo Hyeon, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510932
- Sponsor's protocol ID
- K2025-2257-007
- Acronym
- FIRST-K
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Cruz FM, Wyrwicz L, Stroyakovskiy D, Papai Z, Poureau PG, Liposits G, Cremolini C, Bondarenko I, Modest DP, Benhadji KA, Amellal N, Leger C, Vidot L, Tabernero J; SUNLIGHT Investigators. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. doi: 10.1056/NEJMoa2214963.
PubMed 37133585
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K)
- ClinicalTrials.gov ID
- NCT07510932
- Acronym / sponsor ID
- FIRST-K / K2025-2257-007
- Conditions
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 6 Apr 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.
Background Patients with metastatic colorectal cancer who have progressed after treatment with oxaliplatin- and irinotecan-based chemotherapy, as well as anti-EGFR monoclonal antibodies (cetuximab or panitumumab) according to RAS mutation status, or anti-angiogenic agents (bevacizumab, ramucirumab, or aflibercept), have limited therapeutic options in the third-line setting. The phase III SUNLIGHT trial evaluating TAS-102 (trifluridine/tipiracil) in combination with bevacizumab demonstrated promising outcomes, with a median progression-free survival (PFS) of 5.6 months and a median overall survival (OS) of 10.8 months. However, approximately 30% of patients in that study had not previously received bevacizumab during first- or second-line treatment, indicating that a proportion of patients had not been fully exposed to current standard therapies for metastatic colorectal cancer. Therefore, there remains an unmet need to evaluate additional therapeutic strategies in patients who have received optimal prior standard treatments. This study aims to evaluate the efficacy and safety of fruquintinib as a third-line treatment in this population.
Hypothesis Proactive and comprehensive supportive care will not only help manage fruquintinib-related toxicities (e.g., hypertension, hand-foot syndrome, proteinuria, and fatigue), but also enable patients to maintain treatment, thereby potentially prolonging progression-free survival (PFS).
Study Design This is a multicenter, single-arm, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with supportive care in patients with metastatic colorectal cancer who are intolerant to second-line standard chemotherapy. All subjects will receive fruquintinib treatment in combination with supportive care. Supportive care refers to medical interventions aimed at preventing and managing adverse events associated with fruquintinib, including but not limited to hypertension, proteinuria, diarrhea, fatigue, and hand-foot syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one treatment arm
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib | Experimental | Drug: Fruquintinib |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- [Signed Written Informed Consent]
- Subjects who voluntarily provide signed written informed consent after receiving sufficient explanation of this clinical trial prior to initiation of any study-related procedures.
- [Age and Sex]
- Subjects aged 19 years or older at the time of signing the informed consent.
- For women of childbearing potential, a negative urine β-hCG pregnancy test within 14 days prior to the first administration of the investigational product (IP) is required.
Key exclusion criteria (43 listed)
- Subjects who received an investigational product in another clinical trial within 14 days prior to the first administration of the investigational product in this study.
- Subjects who received cytotoxic chemotherapy within 14 days prior to the first administration of the investigational product, or monoclonal antibody therapy within 4 weeks prior to the first administration of the investigational product.
- Subjects who received radiotherapy involving more than 30% of the bone marrow within 4 weeks prior to the first administration of the investigational product, or palliative radiotherapy to a limited field within 2 weeks prior to the first administration.
- Subjects with persistent toxicities ≥ Grade 1 according to CTCAE from prior anticancer therapy that have not resolved before the first administration of the investigational product (except for alopecia).
- [Medical History and Concurrent Diseases]
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 |
|---|---|---|
| FruquintinibFruquintinib | Drug | Fruquintinib |
Primary outcome
Progression-free survival
Time frame: From initiation of IP drug to progression or death, up to 24 weeks
3 secondary outcomes
Overall survival
Time frame: From initiation of IP drug to death, up to 2 years
Objective response rate
Time frame: up to 24 weeks
Adverse events
Time frame: every visit, up to 24 weeks
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 6 Apr 2026.
- Results publication: PubMed 37133585Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Cruz FM, Wyrwicz L, Stroyakovskiy D, Papai Z, Poureau PG, Liposits G, Cremolini C, Bondarenko I, Modest DP, Benhadji KA, Amellal N, Leger C, Vidot L, Tabernero J; SUNLIGHT Investigators. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. doi: 10.1056/NEJMoa2214963.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib in people with Colon Cancer, run by Korea University Anam Hospital.
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 36 inclusion and 43 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: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jwa Hoon Kim (82-2-2199-3832, jhoonkim@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From initiation of IP drug to progression or death, up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07510932, which also lists 1 linked publication.
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 6 Apr 2026.