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Study on the Safety and Effectiveness of Binimetinib, Lapatinib, and Vinorelbine for Patients with RAS-Mutated Metastatic Colorectal Cancer

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 a type of cancer known as metastatic colorectal cancer, which is a form of cancer that has spread from the colon or rectum to other parts of the body. The study is specifically looking at cases where the cancer has a certain genetic change called a RAS mutation. The purpose of the study is to investigate the safety and effectiveness of a combination of three treatments: binimetinib, lapatinib, and vinorelbine. Binimetinib, also known by its code name MEK162, is a medication that targets specific proteins involved in cancer cell growth. Lapatinib is a medication that blocks certain proteins on the surface of cancer cells, and vinorelbine is a drug that interferes with the growth of cancer cells by targeting their internal structure.

The study will be conducted in two phases. In the first phase, the focus will be on determining the safest dose of the combination of these three treatments. This phase will help identify the best dose to use in the second phase. The second phase will evaluate how well the combination works in treating the cancer. Participants in the study will receive the medications in the form of tablets or through an infusion, which is a way of delivering medication directly into the bloodstream. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, participants will be closely monitored to assess the safety of the treatment and to observe any changes in their cancer. The study aims to provide valuable information on the potential benefits and risks of using this combination of treatments for patients with metastatic colorectal cancer that has a RAS mutation. The results of this study could help improve treatment options for this type of cancer in the future.

The research process

The trial runs in 5 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 undergo initial assessments to confirm eligibility. This includes a review of medical history and a physical examination.
A tumor and skin biopsy will be performed before starting the treatment and after two weeks of therapy.
Step 2
Phase I: dose escalation
The patient will receive a combination of three medications: binimetinib, lapatinib, and vinorelbine.
Binimetinib and lapatinib are taken orally in the form of film-coated tablets. Vinorelbine is administered intravenously as a solution for infusion.
The purpose of this phase is to determine the safest dose of the combination that can be given to patients.
Step 3
Phase II: efficacy evaluation
Once the recommended dose is established, the patient will continue to receive the same combination of medications.
The goal of this phase is to evaluate the effectiveness of the treatment in reducing the size of the cancer.
Step 4
Monitoring and follow-up
Throughout the trial, the patient will have regular check-ups to monitor the response to treatment and any side effects.
Blood samples will be taken periodically to assess the patient's health and the pharmacokinetic profile of the medications.
Step 5
Completion of the trial
The trial is expected to end by June 2025. Upon completion, the patient will have a final assessment to evaluate the overall response to the treatment.

Who can join the trial?

13 criteria

Must have a confirmed diagnosis of colorectal cancer (CRC) that has spread to other parts of the body and has a specific genetic change called a RAS mutation.
Must have tried at least two different standard treatments for this type of cancer, including treatments with drugs like fluoropyrimidine, oxaliplatin, and irinotecan, unless there are medical reasons not to use oxaliplatin or irinotecan.
Must be able to provide a sample of the tumor and skin before starting the study and after two weeks of treatment. The tumor sample must be examined under a microscope.
Any side effects from previous treatments should have improved to a mild level, except for hair loss.
Must have a life expectancy of more than 3 months to allow for proper monitoring of treatment effects.
Women who can have children must have a negative pregnancy test within 14 days before joining the study and agree to use effective birth control during the study and for 4 months after the last treatment.
Must have normal functioning of important organs, such as the liver, kidneys, and heart, as shown by specific medical tests.
Must be at least 18 years old.
Must be able to understand and sign a consent form agreeing to participate in the study.
Must have cancer that can be measured using specific medical guidelines called RECIST 1.1.
Must have a good general health status, as defined by a WHO performance status of 0 or 1, which means fully active or restricted in physically strenuous activity but able to carry out light work.
Must be able to swallow pills and not have any significant digestive issues that could affect how the body absorbs medication.
Must be willing to have blood samples taken as part of the study.

Who cannot join the trial?

4 criteria

Patients who have not been diagnosed with metastatic colorectal cancer with a proven RAS mutation. This means the cancer has spread to other parts of the body and has a specific genetic change.
Patients who have not tried standard treatments for their cancer, which include medicines like 5-FU/capecitabine, oxaliplatin, and irinotecan, unless they cannot take oxaliplatin or irinotecan for medical reasons.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Binimetinib
is a medication used in this trial that works by inhibiting a protein called MEK. This protein is part of a pathway that helps cancer cells grow. By blocking MEK, binimetinib may help slow down or stop the growth of cancer cells.
Lapatinib
is another medication in the trial that targets a protein known as EGFR, which is often found on the surface of cancer cells. By inhibiting this protein, lapatinib can help prevent cancer cells from growing and spreading.
Vinorelbine
is a medication that targets microtubules, which are structures inside cells that help them divide. By interfering with these structures, vinorelbine can help stop cancer cells from multiplying.

What is already known about the treatment

Binimetinib
Binimetinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer with a RAS mutation. The medication works by inhibiting MEK enzymes, which are part of a pathway that helps cancer cells grow. It is classified as a MEK inhibitor.
Lapatinib
Lapatinib is taken orally as a tablet. It is under investigation for its potential to treat metastatic colorectal cancer with a RAS mutation. This medication blocks the EGFR and HER2 receptors, which are involved in the growth and spread of cancer cells. It belongs to the class of pan-EGFR inhibitors.
Vinorelbine
Vinorelbine is administered intravenously. It is being evaluated in clinical trials for its role in treating metastatic colorectal cancer with a RAS mutation. The drug works by disrupting microtubule formation, which is essential for cell division, thereby inhibiting cancer cell growth. It is classified as a microtubule targeting agent (MTA).

Investigated diseases

Metastatic Colorectal Cancer with RAS Mutation – This is a type of colorectal cancer that has spread to other parts of the body and involves a specific genetic mutation known as RAS. The disease typically progresses after standard treatments, such as chemotherapy regimens including 5-FU, capecitabine, oxaliplatin, and irinotecan, have failed. The presence of the RAS mutation can influence how the cancer grows and responds to treatment. As the cancer advances, it may cause symptoms related to the affected organs, such as pain or changes in bowel habits. The progression of the disease can vary, with some patients experiencing rapid growth and others having a slower course. Understanding the genetic makeup of the cancer is crucial for determining potential treatment options.