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New treatment option for Metastatic Colorectal Cancer (CRC)
Official title 5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06887218
What this study is testing
What is Regorafenib (BAY 73-4506)?
Regorafenib (BAY 73-4506) is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer (crc).
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
- This is a non-inferiority randomized phase II trial investigating the efficacy and safety of 5FU/LV in combination with regorafenib for patients with metastatic colorectal cancer in the third-line setting. Patients will be randomly assigned in a 2:1 ratio between 5FU/LV combined with regorafenib or trifluridine-tipiracil (FTD-TPI) plus bevacizumab.
- 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
- Male or female ≥18 years of age.
- Histopathological or cytologically confirmed metastatic CRC.
- Failed second-line therapy for metastatic disease.
- A minimum of one measurable disease per RECISTv1.1.
- ECOG performance status of 0-2.
You likely can't join if
- 1\. Hematology laboratory values of:
- Absolute neutrophil count ≤1000 cells/mm3
- Platelets ≤70,000 cells/mm3
- Hemoglobin ≤9 g/dL
- White blood count ≤3000 cells/mm3. 2. Hepatic laboratory values of aspartate transaminase or alanine aminotransferase:
- \>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or
See the full eligibility criteria
- Male or female ≥18 years of age.
- Histopathological or cytologically confirmed metastatic CRC.
- Failed second-line therapy for metastatic disease.
- A minimum of one measurable disease per RECISTv1.1.
- ECOG performance status of 0-2.
- Life expectancy ≥6 months per treating physician or principal investigator.
- people must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: a. Total bilirubin ≤ 10 x the upper limits of normal (ULN) b. Alanine aminotransferase (ALT) and aspartate...
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically...
- people (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug as outlined in Appendices 12.2
- The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
- Subject must be able to swallow and retain oral medication.
- 1\. Hematology laboratory values of:
- Absolute neutrophil count ≤1000 cells/mm3
- Platelets ≤70,000 cells/mm3
- Hemoglobin ≤9 g/dL
- White blood count ≤3000 cells/mm3. 2. Hepatic laboratory values of aspartate transaminase or alanine aminotransferase:
- \>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or
- \>2.5 × ULN if no liver metastases are present. 3. Serum albumin \ 10 mg/dL. 5. Prothrombin time (PT) or international normalized ratio (INR) \>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant...
- Arrhythmia
- Bradycardia
- Tachycardia
- Symptomatic valvular disease
- Symptomatic congestive heart failure is classified by New York Heart Association as Class III or IV
- Unstable angina pectoris. 11. Myocardial infarction within the past 6 months from the consent date. 12. Active bleeding diathesis. 13. Current complaints of persistent constipation or history of chronic constipation...
- Previous assignment to treatment during this study. people permanently withdrawn from study participation will not be allowed to re-enter study. 23\. Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.