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Compares treatment options for Colorectal Cancer
Official title A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06992258
What this study is testing
What is Fruquintinib+ Lonsurf (trifluridine and tipiracil)?
Fruquintinib+ Lonsurf (trifluridine and tipiracil) is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision to sign and date the consent form
- Able to comply with all study procedures and be available for the duration of the study in the investigator's judgment
- Age ≥18
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma
You likely can't join 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...
- Untreated CNS metastases or known leptomeningeal disease. Patients with treated CNS metastases (either by surgical or radiation techniques) are...
See the full eligibility criteria
Who can join
- Provision to sign and date the consent form
- Able to comply with all study procedures and be available for the duration of the study in the investigator's judgment
- Age ≥18
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 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) for the treatment of advanced or metastatic colorectal cancer...
- Patients who progressed on irinotecan- and oxaliplatin-based regimens previously for metastatic disease should not be retreated with these agents prior to enrolling on this study.
- Patients who developed locally advanced/metastatic disease during or within 6 months of completing adjuvant therapy are eligible and the adjuvant/neoadjuvant therapy can be counted as one regimen of chemotherapy for...
- Mismatch repair proficient (MMRp) status documented by local IHC testing
- RAS and BRAF status documented
- Measurable disease according to RECIST v1.1
- Able to swallow and absorb oral medication
- Adequate hematologic and end organ function, defined by the following laboratory results obtained within 72 hours prior to first dose of study drug treatment:
- ANC ≥ 1.5 × 109/L
- Platelet count ≥ 70 × 109/L
- Hemoglobin ≥ 9 g/dL in the previous week
- Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN); patients with known Gilbert's disease may have a bilirubin ≤ 3.0 ×ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase ALT) \< 3 × upper limit of normal (ULN) (in the presence of liver metastases ≤ 5 × ULN)
- Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault Equation (or similar formula) or as calculated using a timed urine collection
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and...
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential...
What rules you out
- 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...
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessments of the investigational regimen. Patients whose prior or...
- 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...
- 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...
- 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...
- 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...
- Recent COVID-19 diagnosis (symptomatic or asymptomatic). To become eligible (following symptomatic infection), the patient must not have fever for 24 hours (without using medicine to reduce fever), other symptoms have...
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study medications or their classes
- Inability to swallow, retain and/or absorb oral medications
- Pregnant or lactating or intending to become pregnant during the study interval
- Other uncontrolled serious medical or psychiatric illness that would impact study participation and/or follow up in the opinion of the treating investigator
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Lancaster, Pennsylvania, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Miami Beach, Florida, United States; Orlando, Florida, United States; New Brunswick, New Jersey, United States; New York, New York, United States; Lancaster, Pennsylvania, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.