Actively Recruiting
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer
Led by Criterium, Inc. · Updated on 2026-03-17
120
Participants Needed
9
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer
CONDITIONS
Official Title
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Ability to comply with all study procedures and be available for the study duration
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma
- Prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab (unless contraindicated), and cetuximab/panitumumab (for RAS-wild type disease) with disease progression or intolerance
- Patients progressing on irinotecan- and oxaliplatin-based regimens should not be retreated with these agents before enrolling
- Patients with locally advanced/metastatic disease during or within 6 months of completing adjuvant therapy are eligible; those with disease >6 months after completion must be treated with specified therapies
- Mismatch repair proficient (MMRp) status confirmed by local testing
- Documented RAS and BRAF status
- Measurable disease per RECIST v1.1 criteria
- Ability to swallow and absorb oral medication
- Adequate blood counts and organ function as defined by specific laboratory values within 72 hours before first dose
- Women of childbearing potential must agree to effective contraception or abstinence during treatment and for 180 days after
- Men must agree to effective contraception or abstinence during treatment and for 180 days after, and refrain from sperm donation
You will not qualify if you...
- Known microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) status, or unknown status
- Presence of BRAF V600 mutations
- Prior treatment with regorafenib, TAS-102, or fruquintinib
- Major surgery within 14 days before starting study treatment
- Not recovered from significant adverse events of prior therapy
- Untreated central nervous system (CNS) metastases or leptomeningeal disease
- Prior or concurrent malignancy that could interfere with study assessments
- Uncontrolled illnesses including pleural/pericardial effusions requiring drainage, arrhythmias, hypertension, significant proteinuria, severe heart failure, recent angina, active infections requiring IV antibiotics, prolonged QT interval, or severe gastrointestinal conditions
- Recent history of bleeding or thromboembolic events within specified timeframes
- Tumor invasion of large vascular structures
- Inability to stop medications that prolong QT interval
- Use of strong or moderate CYP3A inducers within 7 days before treatment
- Patients with AIDS; HIV patients on effective therapy with undetectable viral load are eligible
- Hepatitis B patients must have undetectable viral load; cured or treated hepatitis C patients are eligible
- Recent COVID-19 infection with specific recovery criteria
- Severe allergic or hypersensitivity reactions to study drugs
- Inability to swallow or absorb oral medications
- Pregnant or lactating women or intending pregnancy during the study
- Other uncontrolled serious medical or psychiatric conditions that could affect participation or follow-up
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
Mount Sinai Cancer Research Program
Miami Beach, Florida, United States, 33140
Actively Recruiting
3
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Actively Recruiting
4
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
5
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
6
UPenn Lancaster-Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
7
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
Mays Cancer Center at University of Texas Health at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
9
Inova Schar Cancer
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Soumaya Chappidi
CONTACT
J
Julee Hartwell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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