A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Co… (NCT07011576) | Clinical Trial Compass
RecruitingPhase 2
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
United States60 participantsStarted 2025-09-29
Plain-language 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). 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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:
* 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
* Participants with uncontrolled hypertension
* Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS) rate at 6 months
Timeframe: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Trial details
NCT IDNCT07011576
SponsorSCRI Development Innovations, LLC
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-01
Contact for this trial
Sarah Cannon Sarah Cannon Development Innovations, LLC