NCT07011576 A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
| NCT ID | NCT07011576 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | SCRI Development Innovations, LLC |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-09-29 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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 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
Contact & Investigator
Sarah Cannon Sarah Cannon Development Innovations, LLC
✉ SCRI.InnovationsMedical@scri.com📞 844-710-6157
Meredith Pelster, MD
STUDY CHAIR
SCRI Oncology Partners
Frequently Asked Questions
Who can join the NCT07011576 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07011576 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07011576 currently recruiting?
Yes, NCT07011576 is actively recruiting participants. Contact the research team at SCRI.InnovationsMedical@scri.com for enrollment information.
Where is the NCT07011576 trial being conducted?
This trial is being conducted at Denver, United States, Arlington Heights, United States, Columbia, United States, Maple Grove, United States and 10 additional locations.
Who is sponsoring the NCT07011576 clinical trial?
NCT07011576 is sponsored by SCRI Development Innovations, LLC. The principal investigator is Meredith Pelster, MD at SCRI Oncology Partners. The trial plans to enroll 60 participants.
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