A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer

Recruiting now · Phase 2

Conditions studied: Colorectal Cancer

In brief

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer

Key facts

Study ID

NCT06992258

Run by

Criterium, Inc.

People needed

120

Starts

2025-10-27

Expected to finish

2028-12-31

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Corrected QT interval using the Fridericia method > 470 msec (repeated demonstration of the QTcF interval if > 470 msec during first assessment) or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as congenital long QT syndrome or family history of long QT syndrome
• History of or active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of obstruction, perforation or fistulas, and any other condition that could, in the investigator's judgment, result in significant gastrointestinal hemorrhage or perforation, within 6 months prior to C1D1.
• History or presence of hemorrhage from any other site (e.g. hemoptysis or hematemesis) within 3 months prior to C1D1.
• History of a venous thromboembolic event (e.g. deep vein thrombosis or pulmonary embolism) within 3 months prior to C1D1.
• History of an arterial thromboembolic event (e.g. stroke/CVA, transient ischemic event, unstable angina, acute myocardial infarction/coronary artery bypass surgery) within 6 months prior to C1D1.
• Tumor invasion of a large vascular structure (e.g. pulmonary artery, superior or inferior vena cava).
• Inability to discontinue medications with a known risk of causing QT prolongation and/or torsades de pointes within 7 days of C1D1.
• Use of strong or moderate inducers of CYP3A within 7 days of C1D1.
• Patients with AIDS. HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load during the screening period are eligible.
• For patients with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy during the screening period. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load during the screening period.

Where it is running

• Yale University — New Haven, Connecticut, United States (enrolling)
• Mount Sinai Cancer Research Program — Miami Beach, Florida, United States (enrolling)
• Orlando Health Cancer Institute — Orlando, Florida, United States (enrolling)
• Rutgers Cancer Institute — New Brunswick, New Jersey, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• UPenn Lancaster-Ann B. Barshinger Cancer Institute — Lancaster, Pennsylvania, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Mays Cancer Center at University of Texas Health at San Antonio — San Antonio, Texas, United States (enrolling)
• Inova Schar Cancer — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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