A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab- based first-line therapy for mCRC
• 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
Locations
United States
Colorado
Rocky Mountain Cancer Center - Primary
RECRUITING
Denver
Maryland
Maryland Oncology Hematology
RECRUITING
Columbia
Minnesota
Minnesota Oncology Hematology - Primary
RECRUITING
Maple Grove
Oregon
Oncology Associates of Oregon - Primary
RECRUITING
Eugene
Northwest Cancer Specialists - Compass
RECRUITING
Portland
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology - Central/South Texas
RECRUITING
Austin
Texas Oncology - Gulf Coast
RECRUITING
Beaumont
Texas Oncology - Northeast Texas
RECRUITING
Tyler
Virginia
Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)
RECRUITING
Salem
Contact Information
Primary
Sarah Cannon Sarah Cannon Development Innovations, LLC
SCRI.InnovationsMedical@scri.com
844-710-6157
Time Frame
Start Date:2025-09-29
Estimated Completion Date:2027-06
Participants
Target number of participants:60
Treatments
Experimental: Fruquinitinib + FOLFIRI
Participants will receive an assigned dose level of fruquintinib in combination with FOLFIRI. Cycles will be 28 days, where participants will take fruquinitinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion (IV) every 2 weeks. Up to 60 participants will be enrolled.