Not recruiting

Study on Napabucasin with FOLFIRI for Adults with Metastatic Colorectal Cancer After Standard Treatments

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of an investigational drug called Napabucasin in treating patients with metastatic colorectal cancer. This type of cancer originates in the colon or rectum and has spread to other parts of the body. The study involves patients who have already received standard treatments for their cancer. The purpose of the study is to compare the overall survival of patients receiving Napabucasin in combination with a chemotherapy regimen known as FOLFIRI and best supportive care, against those receiving Napabucasin with best supportive care alone.

The treatment being studied includes several medications. Napabucasin is taken orally in the form of a capsule. The chemotherapy regimen, FOLFIRI, includes a combination of drugs: Folinic Acid (also known as Leucovorin), Fluorouracil, and Irinotecan. Folinic Acid is given as a solution for injection, Fluorouracil is administered as a solution for injection or infusion, and Irinotecan is provided as a solution for infusion. These medications are administered intravenously, meaning they are given directly into a vein.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will monitor the participants over a period to assess their overall survival, progression-free survival, and response to the treatment. The study will also evaluate the safety of the treatment and its impact on the quality of life of the participants. The trial aims to provide valuable information on the potential benefits of Napabucasin in combination with FOLFIRI for patients with metastatic colorectal cancer who have exhausted other treatment options.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be randomly assigned to one of two groups. This process is called randomization.
The patient will receive either Napabucasin in combination with a chemotherapy regimen called FOLFIRI and best supportive care, or Napabucasin with best supportive care alone.
Step 2
Treatment administration
The treatment involves the administration of several medications. Folinic acid, fluorouracil, and irinotecan hydrochloride trihydrate are given through an intravenous route, which means they are injected directly into a vein.
The medication Napabucasin is taken orally in the form of capsules.
The chemotherapy regimen FOLFIRI is administered every two weeks. The specific dosages and duration of each medication will be determined by the healthcare provider based on the patient's condition and response to treatment.
Step 3
Monitoring and follow-up
Throughout the study, the patient's health and response to the treatment will be closely monitored. This includes regular medical check-ups, blood tests, and imaging studies such as CT or MRI scans to assess the status of the cancer.
The primary goal is to evaluate the overall survival of patients receiving the treatment. Secondary goals include assessing progression-free survival, response rates, disease control, safety, and quality of life.
Step 4
End of study
The study is expected to conclude by September 30, 2025. At the end of the study, the collected data will be analyzed to determine the effectiveness and safety of the treatment.
Patients will receive information about the study results and any further steps regarding their treatment and care.

Who can join the trial?

17 criteria

Must have a **confirmed adenocarcinoma** of the colon or rectum that has spread to other parts of the body (metastatic).
Must have tried and not responded to standard chemotherapy treatments that include specific drugs like fluoropyrimidine, irinotecan, and oxaliplatin.
Must be at least **18 years old**.
Must have a life expectancy of more than **12 weeks**.
Must have an **ECOG Performance Status** of 0 or 1, which is a scale used to assess how a disease affects a patient's daily living abilities.
Must provide written, signed consent to participate in the trial.
Women who can have children must have a negative pregnancy test before starting the trial.
Must have certain blood test results within specific limits, such as:
- **Alanine transaminase (ALT)**: A liver enzyme that should be within a certain range.
- **Hemoglobin (Hgb)**: A protein in red blood cells that should be at a certain level.
- **Total bilirubin**: A substance made during the breakdown of red blood cells that should be within a certain range.
- **Creatinine**: A waste product in the blood that should be within a certain range, indicating kidney function.
- **Absolute neutrophil count**: A type of white blood cell count that should be at a certain level.
- **Platelet count**: A component of blood that helps with clotting, which should be at a certain level.
- Must have a **Body Mass Index (BMI)** over 18 kg/m² and a body weight over 40 kg, with adequate nutritional status.
- Must agree to provide a sample of tumor tissue for specific tests.
- Must have imaging tests like CT or MRI scans done recently to document all sites of disease.
- Must agree to use contraception or take measures to avoid pregnancy during the study and for a specified time after the last dose of the study drug.

Who cannot join the trial?

7 criteria

Patients who do not have a confirmed diagnosis of **adenocarcinoma** of the colon or rectum that has spread to other parts of the body. **Adenocarcinoma** is a type of cancer that starts in glandular cells, which are cells that make mucus and other fluids.
Patients who have not received previous treatment for their cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medications as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are part of a vulnerable population that requires special protection.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Napabucasin
is an experimental medication being studied for its potential to treat metastatic colorectal cancer. It is being tested to see if it can improve survival in patients who have already received other treatments for their cancer.
FOLFIRI
is a combination of chemotherapy drugs used to treat colorectal cancer. It includes three medications: irinotecan, fluorouracil, and leucovorin. This combination works by stopping the growth of cancer cells and is given to patients every two weeks as part of their treatment plan.
Best Supportive Care (BSC)
refers to the care given to improve the quality of life for patients with serious illnesses. It includes treatments to relieve symptoms and side effects, such as pain management, nutritional support, and psychological support, but does not include treatments aimed at curing the disease.

What is already known about the treatment

Napabucasin – Napabucasin is administered orally and is currently being studied in clinical trials for its potential use in treating metastatic colorectal cancer. It is not yet widely adopted in standard medical practice, as it is still under investigation. The main therapeutic indication for Napabucasin is in combination with other treatments for patients with previously treated metastatic colorectal cancer. At the molecular level, Napabucasin works by inhibiting cancer stem cell pathways, which may help to prevent cancer growth and spread. It is classified as an anti-cancer agent, specifically targeting cancer stem cells.

Investigated diseases

Metastatic Adenocarcinoma of the Colon or Rectum – This is a type of cancer that begins in the glandular cells lining the colon or rectum and has spread to other parts of the body. It typically starts as a growth, known as a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the disease progresses, cancer cells can invade nearby tissues and spread to distant organs, such as the liver or lungs, through the bloodstream or lymphatic system. The spread of cancer to other parts of the body is referred to as metastasis, which can complicate treatment and management. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of the disease can vary depending on several factors, including the location and size of the tumor and the overall health of the individual.