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A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
NCT07011576 · SCRI Development Innovations, LLC
In plain English
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Official title
A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
About this study
Fruquintinib is an FDA approved cancer medication that works by targeting proteins called vascular endothelial growth factor receptors (VEGFRs). VEGFRs are important in the creation of new blood vessels. As a highly-selective and potent VEGFR inhibitor, fruquintinib helps block new blood vessels that would provide nutrients and oxygen to cancerous tumors from forming. It is a small molecule anti-tumor drug with a novel chemical structure that belongs to the quinazoline class.
This study is an open-label Phase II study designed to evaluate the efficacy and safety of fruquintinib + FOLFIRI in 2nd-line setting mCRC participants who have been previously treated with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab-based first-line therapy. Up to 60 participants will receive concurrent fruquintinib and FOLFIRI according to standard guidelines of treatment of mCRC.
Eligibility criteria
Key Inclusion Criteria:
* 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
Key Exclusion Criteria:
* Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
* Major surgery within 4 weeks of the first planned dose of study treatment
* More than one treatment received for mCRC prior to signing the ICFs
* Uncontrolled, symptomatic brain metastases
* Uncontrolled, symptomatic gastrointestinal disease
* Patients with uncontrolled hypertension
* Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy
* Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy
* Documented major electrocardiogram (ECG) abnormalities which are clinically significant.
* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
* Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-29
Estimated completion: 2027-06
Last updated: 2026-03-18
Interventions
Drug: fruquintinibDrug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Primary outcomes
- • Progression-Free Survival (PFS) rate at 6 months (Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.)
Sponsor
SCRI Development Innovations, LLC · other
With: Takeda Development Center Americas, Inc.
Contacts & investigators
ContactSarah Cannon Sarah Cannon Development Innovations, LLC · contact · SCRI.InnovationsMedical@scri.com · 844-710-6157
InvestigatorMeredith Pelster, MD · study_chair, SCRI Oncology Partners
All locations (14)
Rocky Mountain Cancer Center - PrimaryRecruiting
Denver, Colorado, United States
Illinois Cancer SpecialistsRecruiting
Arlington Heights, Illinois, United States
Maryland Oncology HematologyRecruiting
Columbia, Maryland, United States
Minnesota Oncology Hematology - PrimaryRecruiting
Maple Grove, Minnesota, United States
Missouri Cancer AssociatesRecruiting
Columbia, Missouri, United States
Oncology Associates of Oregon - PrimaryRecruiting
Eugene, Oregon, United States
Northwest Cancer Specialists - CompassRecruiting
Portland, Oregon, United States
Alliance Cancer SpecialistsRecruiting
Wynnewood, Pennsylvania, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology - Central/South TexasRecruiting
Austin, Texas, United States
Texas Oncology - Gulf CoastRecruiting
Beaumont, Texas, United States
Texas Oncology - Northeast TexasRecruiting
Tyler, Texas, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)Recruiting
Salem, Virginia, United States