Recruiting

Study on the Effectiveness of Tepotinib and Drug Combination for Patients with Advanced Cancer

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What is this trial about?

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

This clinical trial focuses on improving cancer care by using precision medicine in Norway. The study investigates the effectiveness of approved drugs used outside their usual purpose in patients with advanced cancer. The trial aims to explore the anti-tumor activity and safety of these targeted anti-cancer drugs in patients whose cancer has specific genetic or protein changes that are known to respond to these treatments. The study includes a variety of medications, such as TEPOTINIB (also known as TEPMETKO), ALPELISIB (also known as Piqray), OLAPARIB (also known as Lynparza), SELPERCATINIB (also known as Retsevmo), DABRAFENIB (also known as Tafinlar), BEVACIZUMAB (also known as Avastin), CAPMATINIB (also known as Tabrecta), PEMIGATINIB (also known as Pemazyre), VEMURAFENIB (also known as Zelboraf), TRASTUZUMAB and PERTUZUMAB (also known as Phesgo), TRAMETINIB (also known as Mekinist), VISMODEGIB (also known as Erivedge), IMATINIB (also known as Imatinib Teva), ENTRECTINIB (also known as Rozlytrek), ATEZOLIZUMAB (also known as Tecentriq), COBIMETINIB (also known as Cotellic), and FULVESTRANT (also known as Fulvestrant SUN).

The purpose of the study is to provide patients with access to these targeted drugs, which may be effective for treating advanced cancer with specific genetic or protein changes. The trial will observe how well these drugs work and their safety in patients. The study will last for a period of time, during which patients will receive the treatment and be monitored for any effects. Some patients may receive a placebo, which is a substance with no active drug, to compare the effects of the actual drugs being tested.

Participants in the study will take the medications in various forms, such as tablets, capsules, or injections, depending on the specific drug. The study will help determine the percentage of patients who benefit from treatment based on their cancer's molecular profile and will also track any serious side effects related to the treatment. The trial aims to improve the understanding of how these drugs can be used to treat advanced cancer more effectively.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria, including a performance status and life expectancy.
A genomic or molecular test is required to identify a suitable treatment based on the tumor profile.
Step 2
Treatment assignment
Treatment is assigned based on the genomic profile of the tumor. This involves using targeted anti-cancer drugs that are commercially available.
The drugs are selected for their potential efficacy in treating advanced cancer with specific genomic or protein expression variants.
Step 3
Medication administration
Medications are administered according to their specific routes, such as oral or intravenous use.
Examples of medications include tepotinib (oral), alpelisib (oral), and bevacizumab (intravenous).
Dosages and frequency depend on the specific drug and its formulation, such as film-coated tablets or solutions for infusion.
Step 4
Monitoring and evaluation
Regular monitoring is conducted to assess the anti-tumor activity and any side effects of the treatment.
The primary focus is on the percentage of patients treated based on their molecular tumor profile and any serious adverse events.
Step 5
Progress assessment
Progression-free survival and overall survival are evaluated as secondary endpoints.
The duration of time on the drug is also monitored to assess its effectiveness and tolerability.
Step 6
Completion of the study
The study is estimated to conclude by December 31, 2032.
Final assessments will be made regarding the efficacy and safety of the treatments based on the collected data.

Who can join the trial?

15 criteria

The patient must have a type of cancer that is either locally advanced or has spread to other parts of the body.
The patient should not be benefiting from standard cancer treatments, or no such treatments should be available or suitable according to the doctor's opinion.
The patient must have a genomic profile that suggests potential benefit from one of the approved targeted anti-cancer therapies in the study. A genomic profile is a test that looks at the genes in the cancer cells to find specific changes that might be treated with certain drugs.
The patient must have results from a genomic or molecular test done in a preapproved laboratory. This test can be done on a sample of the patient's tumor or through a blood test called a "liquid biopsy."
The patient must have an ECOG performance status of 0-2. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 2 indicating some limitations.
The patient should have a life expectancy of at least 3 months.
The patient must have acceptable organ function, which includes:
- A certain level of white blood cells called neutrophils (at least 1.5 x 10⁹ per liter).
- A hemoglobin level greater than 9 grams per deciliter, which is a measure of red blood cells.
- A platelet count greater than 75,000 per microliter, which helps with blood clotting.
- Total bilirubin less than 1.5 times the normal upper limit. Bilirubin is a substance made by the liver.
- AST and ALT levels less than 2.5 times the normal upper limit, or less than 5 times if there are liver metastases. These are liver enzymes.
- Creatinine clearance of at least 40 mL/min/1.73 m², which measures kidney function.
- If the treatment is taken by mouth, the patient must be able to swallow and tolerate oral medication and should not have any known issues with absorbing nutrients from food.
- The study is open to both male and female patients.
- The study includes patients who might be considered vulnerable, meaning they may need extra protection or care.

Who cannot join the trial?

10 criteria

Patients who do not have a type of cancer that is being studied in this trial.
Patients who do not have a specific change in their genes or proteins that the study drugs are designed to target.
Patients who are not in the age range specified for the trial.
Patients who are not able to safely take the study drugs due to other health conditions.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who are participating in another clinical trial that could interfere with this study.
Patients who have had a recent major surgery or are recovering from a major illness.
Patients who have a history of allergic reactions to the study drugs or similar medications.
Patients who have certain infections that could affect their participation in the trial.

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Verified sites

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Responsive
Sykehuset I Vestfold HF
Tonsberg, Norway
Responsive
Sykehuset Oestfold HF Kalnes
Graalum, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

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Investigated drugs

Trastuzumab
is a medication used to treat certain types of breast cancer. It works by targeting a specific protein on cancer cells, helping to slow or stop their growth.
Imatinib
is used to treat certain types of cancer by blocking the action of a protein that causes cancer cells to multiply. It is often used for chronic myeloid leukemia and gastrointestinal stromal tumors.
Gefitinib
is a drug used to treat non-small cell lung cancer. It works by blocking a protein that signals cancer cells to grow.
Vemurafenib
is used to treat melanoma, a type of skin cancer, that has spread or cannot be removed by surgery. It targets a specific mutation in the cancer cells to help stop their growth.
Crizotinib
is used for treating non-small cell lung cancer. It targets specific proteins in cancer cells to help slow down their growth and spread.
Olaparib
is a medication used to treat certain types of ovarian and breast cancers. It works by interfering with the cancer cells' ability to repair their DNA, leading to cell death.

What is already known about the treatment

Imatinib – Imatinib is administered orally in tablet form. It is currently well-established in medical literature as a treatment for certain types of cancer, particularly chronic myeloid leukemia and gastrointestinal stromal tumors. The main therapeutic indication for Imatinib is targeting cancer cells that have specific genetic mutations. At the molecular level, Imatinib works by inhibiting a specific enzyme called tyrosine kinase, which is involved in the growth and division of cancer cells. It is classified as a tyrosine kinase inhibitor in pharmacology.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells can invade nearby tissues and form tumors, which may disrupt normal bodily functions. As cancer progresses, it can metastasize, meaning it spreads to other parts of the body through the blood or lymphatic system. The progression of cancer varies depending on the type and location of the cancer, as well as individual factors such as genetics and lifestyle. Cancer can affect almost any part of the body and is often named for the organ or tissue where it originates. The disease can be influenced by genetic mutations or environmental factors, leading to a wide range of symptoms and complications.