RecruitingPhase 2NCT07011576

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

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


Sponsor

SCRI Development Innovations, LLC

Enrollment

60 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug combination — fruquintinib (a targeted therapy) plus FOLFIRI (a standard chemotherapy regimen) — as a second-line treatment for people with metastatic colorectal cancer (cancer that has spread from the colon or rectum to other organs). **You may be eligible if...** - You are 18 or older - You have metastatic colorectal cancer confirmed by biopsy - You previously received a standard first-line chemotherapy regimen containing oxaliplatin and bevacizumab, and your cancer has since progressed - You have at least one measurable tumor lesion on a scan **You may NOT be eligible if...** - Your colorectal cancer is microsatellite instability-high (MSI-H) or has a BRAF V600 mutation - You have already received more than one prior treatment for metastatic disease - You have significant heart disease or uncontrolled high blood pressure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGfruquintinib

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

DRUGFOLFIRI (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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07011576


Related Trials