Colon CancerPhase 2FRUITFULNCT07011576
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
A Phase 2 study testing fruquintinib and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in people with Colon Cancer and Rectal Cancer, run by SCRI Development Innovations, LLC at 14 sites in United States.
Trial summary
This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Colorectal Cancer
- What is being tested?
- fruquintinib and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 14 sitesUnited States
- Study dates
- 29 Sep 2025to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
- Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
- Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.
- At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
Who cannot join
- Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
- Major surgery within 4 weeks of the first planned dose of study treatment
- More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
- Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
- Uncontrolled, symptomatic brain metastases
- Uncontrolled, symptomatic gastrointestinal disease
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- Participants with uncontrolled hypertension
- Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy
- Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy
- Documented major electrocardiogram (ECG) abnormalities which are clinically significant.
- Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
- Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Cannon Sarah Cannon Development Innovations, LLC contact
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
- Recruiting
Texas Oncology - Central/South Texas
Austin, Texas, 78705
- Recruiting
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702
- Recruiting
Maryland Oncology Hematology
Columbia, Maryland, 21044
- Recruiting
Missouri Cancer Associates
Columbia, Missouri, 65201
- Recruiting
Rocky Mountain Cancer Center - Primary
Denver, Colorado, 80218
- Recruiting
Oncology Associates of Oregon - Primary
Eugene, Oregon, 97401
- Recruiting
Minnesota Oncology Hematology - Primary
Maple Grove, Minnesota, 55369
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
- Recruiting
Northwest Cancer Specialists - Compass
Portland, Oregon, 97213
- Recruiting
Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)
Salem, Virginia, 24153
- Recruiting
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
- Recruiting
Alliance Cancer Specialists
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:
- Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting
- Evaluate the safety of the combination of fruquintinib + FOLFIRI
Read the detailed description
Fruquintinib is an FDA approved cancer medication that works by targeting proteins called vascular endothelial growth factor receptors (VEGFRs). VEGFRs are important in the creation of new blood vessels. As a highly-selective and potent VEGFR inhibitor, fruquintinib helps block new blood vessels that would provide nutrients and oxygen to cancerous tumors from forming. It is a small molecule anti-tumor drug with a novel chemical structure that belongs to the quinazoline class.
This study is an open-label Phase II study designed to evaluate the efficacy and safety of fruquintinib + FOLFIRI in 2nd-line setting mCRC participants who have been previously treated with oxaliplatin, a fluoropyrimidine, and bevacizumab (BEV) for first line of therapy. Up to 60 participants will receive concurrent fruquintinib and FOLFIRI according to standard guidelines of treatment of mCRC.
- Being tested
- fruquintinib, FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
- Keywords
- Colorectal cancer, Colon Cancer, Rectal cancer, Metastatic colorectal cancer, mCRC, VEGFR inhibitor, Fruquintinib, FOLFIRI, Second line, 2L mCRC
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruquintinibDrug
Also called Fruzaqla
Participants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle.
FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)Drug
Participants will receive FOLFIRI once every 2 weeks on day 1 of every 28-day cycle (twice in each cycle). The FOLFIRI regimen consists of irinotecan given 180 mg/m2 intravenous infusion (IV), leucovorin 400 mg/m2 (or 200 mg/m2 levoleucovorin) IV, followed by 5-fluorouracil (5-FU) 400 mg/m2 bolus injection and 5-FU continuous IV infusion of 2400 mg/m2 over 46 to 48 hours. The 5-FU Bolus may be omitted starting from Cycle 1 Day 1 at the investigators discretion, specifically in participants with a history of cytopenias or toxicities within the first line of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Fruquinitinib + FOLFIRI | Experimental | Participants will receive an assigned dose level of fruquintinib in combination with FOLFIRI. Cycles will be 28 days, where participants will take fruquinitinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion (IV) every 2 weeks. Up to 60 participants will be enrolled. Receives: Drug: fruquintinib; Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) rate at 6 months
Progression-Free Survival (PFS) rate at 6 months, defined as the percentage of participants at 6 months who have not experienced disease progression as defined by the RECIST Version 1.1 criteria or death on study. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment.
Measured: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Secondary outcomes (5)
Overall Response Rate (ORR)
Objective Response Rate (ORR), defined as the proportion of participants with confirmed CR or PR (i.e., 2 CRs or PRs at least 4 weeks apart) according to the RECIST Version 1.1.
Measured: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Duration of response (DoR)
Duration of Response (DoR), defined as the duration from the first documented response to the date of first documented PD or death due to any cause. In case a participant does not experience PD or death, DoR is censored at the date of last adequate tumor assessment (defined as an assessment of CR, PR, or SD). DoR analysis will include only responders (PR or better).
Measured: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Disease control response rate (DCR)
Disease Control Response Rate (DCR), defined as the proportion of participants with a best overall response of CR, PR, or SD.
Measured: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Number of participants with treatment emergent adverse events
Using CTCAE V5.0
Measured: Every 28 day cycle, from signed informed consent to 30 days after treatment discontinuation up to 1 year.
Overall Survival (OS)
Overall Survival (OS), defined as the time from the first day of study drug administration (Day 1) to death. Participants who are alive will be censored at the date of last known date alive. Each cycle is 28 days.
Measured: From cycle 1 day 1 up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2025
- Study start29 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Meredith Pelster, MD, Study chair, SCRI Oncology Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011576
- Sponsor's protocol ID
- GI 387
- Acronym
- FRUITFUL
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
- ClinicalTrials.gov ID
- NCT07011576
- Acronym / sponsor ID
- FRUITFUL / GI 387
- Keywords
- Colorectal cancer, Colon Cancer, Rectal cancer, Metastatic colorectal cancer, mCRC, VEGFR inhibitor, Fruquintinib, FOLFIRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Takeda Development Center Americas, Inc.
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 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.
This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:
- Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting
- Evaluate the safety of the combination of fruquintinib + FOLFIRI
Detailed description
Fruquintinib is an FDA approved cancer medication that works by targeting proteins called vascular endothelial growth factor receptors (VEGFRs). VEGFRs are important in the creation of new blood vessels. As a highly-selective and potent VEGFR inhibitor, fruquintinib helps block new blood vessels that would provide nutrients and oxygen to cancerous tumors from forming. It is a small molecule anti-tumor drug with a novel chemical structure that belongs to the quinazoline class.
This study is an open-label Phase II study designed to evaluate the efficacy and safety of fruquintinib + FOLFIRI in 2nd-line setting mCRC participants who have been previously treated with oxaliplatin, a fluoropyrimidine, and bevacizumab (BEV) for first line of therapy. Up to 60 participants will receive concurrent fruquintinib and FOLFIRI according to standard guidelines of treatment of mCRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquinitinib + FOLFIRI | Experimental | Drug: fruquintinib, Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)Participants will receive an assigned dose level of fruquintinib in combination with FOLFIRI. Cycles will be 28 days, where participants will take fruquinitinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion (IV) every 2 weeks. Up to 60 participants will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
- Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
- Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.
- At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
Key exclusion criteria (12 listed)
- Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
- Major surgery within 4 weeks of the first planned dose of study treatment
- More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
- Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
- Uncontrolled, symptomatic brain metastases
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 |
|---|---|---|
| fruquintinibAlso: FruzaqlaParticipants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle. | Drug | Fruquinitinib + FOLFIRI |
| FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)Participants will receive FOLFIRI once every 2 weeks on day 1 of every 28-day cycle (twice in each cycle). The FOLFIRI regimen consists of irinotecan given 180 mg/m2 intravenous infusion (IV), leucovorin 400 mg/m2 (or 200 mg/m2 levoleucovorin) IV, followed by 5-fluorouracil (5-FU) 400 mg/m2 bolus injection and 5-FU continuous IV infusion of 2400 mg/m2 over 46 to 48 hours. The 5-FU Bolus may be omitted starting from Cycle 1 Day 1 at the investigators discretion, specifically in participants with a history of cytopenias or toxicities within the first line of treatment. | Drug | Fruquinitinib + FOLFIRI |
Primary outcome
Progression-Free Survival (PFS) rate at 6 months
Time frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Progression-Free Survival (PFS) rate at 6 months, defined as the percentage of participants at 6 months who have not experienced disease progression as defined by the RECIST Version 1.1 criteria or death on study. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment.
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Duration of response (DoR)
Time frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Disease control response rate (DCR)
Time frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Number of participants with treatment emergent adverse events
Time frame: Every 28 day cycle, from signed informed consent to 30 days after treatment discontinuation up to 1 year.
Overall Survival (OS)
Time frame: From cycle 1 day 1 up to 2 years
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 12 Jun 2026.
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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.
Sarah Cannon Sarah Cannon Development Innovations, LLC contact
Meredith Pelster, MD study chair
SCRI Oncology Partners
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fruquintinib and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in people with Colon Cancer and Rectal Cancer, run by SCRI Development Innovations, LLC at 14 sites in United States.
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 5 inclusion and 12 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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.
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 Sarah Cannon Sarah Cannon Development Innovations, LLC (844-710-6157, SCRI.InnovationsMedical@scri.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) rate at 6 months (time frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.). 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 12 Jun 2026.