A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer
FRUITION
1 other identifier
interventional
120
1 country
9
Brief Summary
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Oct 2025
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 28, 2025
CompletedStudy Start
First participant enrolled
October 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 17, 2026
March 1, 2026
2.2 years
April 30, 2025
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To estimate the progression-free survival (PFS) benefit of fruquintinib in combination with TAS-102 as compared to fruquintinib
Progression free survival (PFS) defined as time from randomization to first observation of progression using RECIST v1.1 or death from any cause.
24 months
Secondary Outcomes (5)
Estimate the confirmed objective response rate (ORR) of fruquintinib in combination with TAS-102 as compared to fruquintinib
24 months
Estimate the disease control rate (DCR) of fruquintinib in combination with TAS-102 as compared to fruquintinib
24 months
Estimate the clinical benefit rate (CBR) of fruquintinib in combination with TAS-102 as compared to fruquintinib
24 months
Estimate the overall survival (OS) of fruquintinib in combination with TAS-102 as compared to fruquintinib
24 months
Characterize the toxicity profile of fruquintinib in combination with TAS-102
24 months
Study Arms (2)
Fruquintinib and Lonsurf
EXPERIMENTALFruquintinib
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may not qualify if:
- Patients with known MSI-high or mismatch repair deficient (dMMR) status or in whom the status of both are unknown
- Patients with BRAF V600 mutations
- Prior treatment with regorafenib, trifluridine-tipiracil (TAS-102), or fruquintinib.
- Major surgery within 14 days of C1D1. Minor procedures (e.g. biopsies, central venous catheters) are not considered major surgery.
- Patients must have recovered from clinically significant AEs of their most recent prior therapy/intervention prior to enrollment as determined by relevant clinical and laboratory parameters.
- Untreated CNS metastases or known leptomeningeal disease. Patients with treated CNS metastases (either by surgical or radiation techniques) are eligible provided there is no evidence of progression for at least 4 weeks after CNS-directed therapy as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments of the investigational regimen. Patients whose prior or concurrent malignancy natural history and/or treatment does NOT have the potential to impact safety or study assessments are eligible.
- Uncontrolled intercurrent illness (defined as but not limited to others in the opinion of the treating investigator):
- Uncontrolled pleural effusion, pericardial effusion or ascites defined as requiring recurrent drainage procedures within 3 weeks of C1D1
- Uncontrolled arrhythmia or any ventricular arrhythmia requiring treatment
- Uncontrolled hypertension (≥ 160 mmHg systolic or ≥ 100mmHg diastolic in spite of maximal medical therapy)
- Urine dipstick or urinalysis with protein ≥ 2+ or 24-hour urine protein ≥ 1.0g/24 hours. Patients with 1+ proteinuria must undergo a urine protein creatinine ratio (UPCR) or 24-hour urine collection to assess protein level. For interpretation of lab values for proteinuria please see Appendix E.
- New York Heart Association (NYHA) Functional Classification class 3 or 4 congestive heart failure or left ventricular ejection fraction \< 50%
- Severe or unstable angina within 3 months prior to C1D1
- Active infection requiring IV antibiotics within 1 week prior to C1D1. Antibiotics used for prophylactic purposes are allowed.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Criterium, Inc.lead
Study Sites (9)
Yale University
New Haven, Connecticut, 06520, United States
Mount Sinai Cancer Research Program
Miami Beach, Florida, 33140, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08903, United States
NYU Langone Health
New York, New York, 10016, United States
UPenn Lancaster-Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Mays Cancer Center at University of Texas Health at San Antonio
San Antonio, Texas, 78229, United States
Inova Schar Cancer
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2025
First Posted
May 28, 2025
Study Start
October 27, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share