Clinical trial 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, 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 study is testing whether a new drug mix works as well as a standard mix. It also checks how safe the new mix is.
- Who it's for
- You may be able to join if you have colorectal cancer that has spread.
- What's involved
- You would get one of two drug mixes. You would take pills or get IV infusions. You would have regular check-ups.
- Time commitment
- The study lasts up to 12 cycles of treatment.
- 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
- Absolute neutrophil count ≤1000 cells/mm3
- Platelets ≤70,000 cells/mm3
- Hemoglobin ≤9 g/dL
- \>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.
- Arrhythmia
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.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug.
- 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.
- Absolute neutrophil count ≤1000 cells/mm3
- Platelets ≤70,000 cells/mm3
- Hemoglobin ≤9 g/dL
- \>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.
- 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.
- Previous assignment to treatment during this study. people permanently withdrawn from study participation will not be allowed to re-enter study. 23\.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.