A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
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
Interventions
fruquintinib
FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Conditions
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