Recruiting

Study on Personalized Treatment for Metastatic Colorectal Cancer Using Methotrexate and Drug Combination for Patients with Advanced Disease

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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 treatments for metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and spreads to other parts of the body. The study aims to explore the effectiveness of personalized treatments based on detailed genetic profiling and testing of cancer cells taken from patients. This approach helps in identifying the most suitable treatment for each individual patient.

The trial involves several medications, including Methotrexate, Mektovi (also known as binimetinib or MEK162), IBRANCE (also known as palbociclib), Afinitor (also known as everolimus), Venclyxto (also known as venetoclax or ABT-199), XALKORI (also known as crizotinib), SPRYCEL (also known as dasatinib), Herceptin (also known as trastuzumab), Zydelig (also known as idelalisib), Gemcitabine, Talzenna (also known as talazoparib), KEYTRUDA (also known as pembrolizumab), Alecensa (also known as alectinib), and Farydak (also known as panobinostat). Some patients may receive a placebo as part of the study. The purpose of the study is to evaluate how well these treatments work in shrinking tumors and improving patient outcomes.

Participants in the study will undergo a pre-screening process where a sample of their tumor is taken to create a genetic profile. This profile helps in selecting the most appropriate treatment. The main study will then involve administering the selected treatment and monitoring the patient's response over a period of time. The study will assess the effectiveness of the treatment by measuring the reduction in tumor size and other health indicators. The trial is designed to last up to 12 months for most treatments, with some extending to 24 months, and aims to provide insights into the best treatment options for patients with metastatic colorectal cancer.

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, a tumor biopsy is performed to create a full pharmacogenomic profile. This profile helps in selecting a personalized treatment plan.
Step 2
Treatment selection
Based on the pharmacogenomic profile, a treatment is selected from a list of medications. These medications are not typically used in standard care for metastatic colorectal cancer.
Step 3
Medication administration
The selected medication is administered according to its specific route and form. For example, Methotrexate is given as an injection, while Binimetinib is taken orally as a film-coated tablet.
Other medications like Palbociclib and Everolimus are also taken orally in capsule or tablet form. Trastuzumab is administered intravenously as a solution for infusion.
Step 4
Monitoring and evaluation
Throughout the study, the response to the treatment is monitored. This includes measuring the objective response rate, which assesses the reduction in tumor size.
The duration of response and progression-free survival are also evaluated to determine the effectiveness of the treatment.
Step 5
Completion of study
The study is estimated to conclude by December 31, 2040. At the end of the study, the overall survival rate and any adverse events are recorded.

Who can join the trial?

13 criteria

The patient must have a type of cancer called **colorectal cancer**, which affects the colon or rectum.
The patient must have a confirmed diagnosis of **locally advanced or metastatic adenocarcinoma** from the colon or rectum. This means the cancer has spread beyond its original location.
The patient must have a disease that can be measured or evaluated using specific medical guidelines (RECIST v1.1).
The patient must have an **ECOG performance status** of 0 or 1, which indicates they are fully active or have some symptoms but can still carry out light work.
The patient must be able to swallow and tolerate oral medication, and should not have any known issues with absorbing nutrients from food.
Women who can become pregnant and men must agree to use effective birth control methods to prevent pregnancy during the study.
The patient must have acceptable organ function, which will be checked by the study team.
The patient must have received or be receiving systemic treatment for metastatic colorectal cancer (mCRC), which is treatment that affects the entire body.
The patient must have **non-resectable metastases**, meaning the cancer has spread and cannot be removed by surgery, and be eligible for a biopsy, which is a procedure to take a small sample of tissue for testing.
The patient must be able to understand and sign an informed consent form, agreeing to the study's requirements and restrictions.
The patient must have received at least two lines of standard chemotherapy for mCRC, which means they have tried at least two different treatment plans.
The patient must have a complete **pharmacogenomic profile**, which is a detailed analysis of their tumor's genetic makeup and how it responds to drugs, to help decide on a targeted treatment.
The study is open to both male and female participants.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than colorectal cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to provide a tumor biopsy for analysis cannot participate.
Patients who are already receiving treatments that are part of the standard care for metastatic colorectal cancer (mCRC) cannot participate.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.
Patients who have any other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are part of a vulnerable population that requires special protection cannot participate.

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Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

MTB-nominated therapies: These are treatments chosen based on a detailed analysis of the tumor's genetic profile and how the cancer cells respond to different drugs in a lab setting. The goal is to find a personalized treatment plan that is not typically used in standard care for patients with metastatic colorectal cancer.

What is already known about the treatment

MTB-Nominated Therapy – This medication is administered based on a personalized approach, using pharmacogenomic profiling and drug sensitivity testing to tailor treatment for patients with metastatic colorectal cancer. It is currently being studied in clinical trials and is not yet approved for standard clinical practice. The main therapeutic indication is for colorectal cancer, specifically in cases where the cancer has spread to other parts of the body. The mechanism of action involves targeting specific genetic and molecular characteristics of the tumor, which are identified through advanced testing. This medication falls under the category of targeted cancer therapies, aiming to improve outcomes by focusing on the unique aspects of each patient's cancer.

Investigated diseases

Colorectal cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. The disease may progress slowly and can spread to other parts of the body if not detected early. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others may metastasize to distant organs.