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NCT07011576PHASE2Recruiting

A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)

SCRI Development Innovations, LLC

Start Date

9/29/2025

Completion Date

6/1/2027

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

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

fruquintinib

DRUG

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

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Conditions

Colon CancerRectal CancerColorectal CancerColorectal Cancer (CRC)

Locations

Rocky Mountain Cancer Center - Primary

Denver, Colorado 80218

United States

Illinois Cancer Specialists

Arlington Heights, Illinois 60005

United States

Maryland Oncology Hematology

Columbia, Maryland 21044

United States

Minnesota Oncology Hematology - Primary

Maple Grove, Minnesota 55369

United States

Missouri Cancer Associates

Columbia, Missouri 65201

United States

Oncology Associates of Oregon - Primary

Eugene, Oregon 97401

United States

Northwest Cancer Specialists - Compass

Portland, Oregon 97213

United States

Alliance Cancer Specialists

Wynnewood, Pennsylvania 19096

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Texas Oncology - Central/South Texas

Austin, Texas 78705

United States

Texas Oncology - Gulf Coast

Beaumont, Texas 77702

United States

Texas Oncology - Northeast Texas

Tyler, Texas 75702

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)

Salem, Virginia 24153

United States