Actively Recruiting
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
Led by SCRI Development Innovations, LLC · Updated on 2026-03-18
60
Participants Needed
14
Research Sites
87 weeks
Total Duration
On this page
Sponsors
S
SCRI Development Innovations, LLC
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed metastatic colorectal cancer with histologically documented adenocarcinoma of the colon or rectum and at least one measurable lesion according to RECIST v1
- Genetic aberrations allowed except for microsatellite instability high (MSI-H) and BRAF V600
- Prior treatment with FOLFOX and Bevacizumab-based first-line therapy for mCRC
- At least 18 years old at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status score between 0 and 2
You will not qualify if you...
- Receiving other anticancer treatments within 21 days before the first study dose
- Major surgery within 4 weeks before the first planned study dose
- More than one prior treatment received for mCRC before signing consent
- Uncontrolled or symptomatic brain metastases
- Uncontrolled or symptomatic gastrointestinal disease
- Uncontrolled hypertension
- Women who are pregnant, nursing, or planning pregnancy during the study and for 6 months after chemotherapy
- Men planning to father a child during the study and for 6 months after chemotherapy
- Clinically significant major electrocardiogram (ECG) abnormalities
- Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring treatment
- Other active invasive cancers within 5 years prior to screening except the cancer treated in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Rocky Mountain Cancer Center - Primary
Denver, Colorado, United States, 80218
Actively Recruiting
2
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Actively Recruiting
3
Maryland Oncology Hematology
Columbia, Maryland, United States, 21044
Actively Recruiting
4
Minnesota Oncology Hematology - Primary
Maple Grove, Minnesota, United States, 55369
Actively Recruiting
5
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Actively Recruiting
6
Oncology Associates of Oregon - Primary
Eugene, Oregon, United States, 97401
Actively Recruiting
7
Northwest Cancer Specialists - Compass
Portland, Oregon, United States, 97213
Actively Recruiting
8
Alliance Cancer Specialists
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
9
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78705
Actively Recruiting
11
Texas Oncology - Gulf Coast
Beaumont, Texas, United States, 77702
Actively Recruiting
12
Texas Oncology - Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
13
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
14
Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)
Salem, Virginia, United States, 24153
Actively Recruiting
Research Team
S
Sarah Cannon Sarah Cannon Development Innovations, LLC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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