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A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
Sponsor: SCRI Development Innovations, LLC
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
Official title: A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-09-29
Completion Date
2027-06
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
fruquintinib
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)
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.
Locations (14)
Rocky Mountain Cancer Center - Primary
Denver, Colorado, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Maryland Oncology Hematology
Columbia, Maryland, United States
Minnesota Oncology Hematology - Primary
Maple Grove, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Oncology Associates of Oregon - Primary
Eugene, Oregon, United States
Northwest Cancer Specialists - Compass
Portland, Oregon, United States
Alliance Cancer Specialists
Wynnewood, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas
Austin, Texas, United States
Texas Oncology - Gulf Coast
Beaumont, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)
Salem, Virginia, United States