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RECRUITING
NCT07011576
PHASE2

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

Sponsor: SCRI Development Innovations, LLC

View on ClinicalTrials.gov

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

DRUG

fruquintinib

Participants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle.

DRUG

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