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Study on Dabrafenib, Trametinib, and Imatinib for Patients with Rare and Hard-to-Treat Cancers

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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 finding new ways to treat rare and hard-to-treat cancers using existing medications. The study will explore the effectiveness of several drugs, including Tafinlar (also known as dabrafenib), Mekinist (also known as trametinib), and Imatinib Teva (also known as imatinib). These medications are already approved for use in other types of cancer, and the trial aims to see if they can be beneficial for patients with rare cancers that are difficult to treat.

The purpose of the study is to understand how well these drugs work against tumors and to monitor any serious side effects that may occur. Participants will take the medications orally, either as capsules or tablets, over a period of time. The study will track the progress of the disease and any changes in the patient's condition. The trial will also look at how long patients can live without the cancer getting worse and their overall survival during the study period.

By repurposing these drugs, the study hopes to provide new treatment options for patients with limited choices. The trial will gather information on the safety and effectiveness of these medications in treating rare cancers, potentially leading to new ways to manage these challenging conditions.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary diagnostic tests to ensure the patient meets the study criteria.
Step 2
Treatment plan development
A personalized treatment plan is developed based on the patient's genomic profile. This plan includes the selection of targeted anti-cancer drugs that are part of the study.
Step 3
Medication administration
The patient begins taking the prescribed medications. These may include dabrafenib (Tafinlar 50 mg or 75 mg hard capsules), trametinib (Mekinist 2 mg or 0.5 mg film-coated tablets), imatinib (Imatinib Teva 100 mg or 400 mg film-coated tablets), or Finlee 10 mg dispersible tablets. All medications are taken orally.
The dosage and frequency depend on the specific medication and the patient's treatment plan. The duration of administration is determined by the study protocol and the patient's response to treatment.
Step 4
Monitoring and evaluation
Regular monitoring is conducted to evaluate the patient's response to treatment. This includes assessing disease control at 16 weeks after treatment initiation and monitoring for any treatment-related adverse events.
Progression-free survival and overall survival are also tracked as part of the study's secondary endpoints.
Step 5
Adjustments and follow-up
Based on the patient's response and any side effects experienced, adjustments to the treatment plan may be made. Follow-up assessments are conducted to ensure the patient's safety and to evaluate the effectiveness of the treatment.

Who can join the trial?

13 criteria

Patients must have a **rare cancer**, which means it affects fewer than 6 out of 100,000 people each year.
Patients must have **advanced cancer** with no effective treatment options available.
Patients must be at least **18 years old**.
Patients must have a **life expectancy** of at least 3 months.
Patients must have a **performance status** of 0-2 on the ECOG scale, which measures how well they can perform daily activities.
Patients must have **evaluable disease**, meaning the cancer can be measured or assessed.
Patients must have **acceptable organ function**, which includes specific blood and liver function levels.
Patients must not have any known **malabsorption syndrome**, which affects how the body absorbs nutrients from food.
Patients must have a **genomic profile** that shows potential benefit from the targeted anti-cancer therapies in the study.
Patients must agree to use **effective contraception** if they are of child-bearing potential, to prevent pregnancy during and after the study.
Women of child-bearing potential must have a **negative pregnancy test** before starting treatment and regularly during the study.
Male patients must agree to use **barrier contraception** to prevent pregnancy during and after the study.
Patients must be able to understand and sign a **written informed consent** document, agreeing to the study's requirements and restrictions.

Who cannot join the trial?

5 criteria

Patients who do not have **cancer** cannot participate. **Cancer** is a disease where cells in the body grow uncontrollably.
Patients who are not within the specified age range cannot participate. The age range includes both children and adults.
Patients who are not part of the specified clinical trial groups cannot participate. Clinical trial groups are specific categories of patients that the study is focusing on.
Both **male** and **female** patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a **vulnerable population** are not excluded. A **vulnerable population** includes groups that may need special protection, but this study does not exclude them.

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Verified sites

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

Verified
Akershus University Hospital
Lorenskog, Norway
Responsive
Sykehuset Oestfold HF Kalnes
Graalum, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

Trial locations

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Investigated drugs

Targeted Anti-Cancer Drugs are medications used in this trial to treat patients with rare and hard-to-treat cancers. These drugs are designed to specifically target and attack cancer cells while minimizing damage to normal cells. They work by interfering with specific molecules involved in the growth, progression, and spread of cancer. The goal of using these drugs in the trial is to evaluate their effectiveness in shrinking tumors and to monitor any serious side effects that may occur during treatment.

What is already known about the treatment

Precision Cancer Medicine – This medication is administered orally or intravenously, depending on the specific drug being repurposed for the treatment of rare and hard-to-treat cancers. Currently, it is part of clinical trials aimed at evaluating its effectiveness and safety in treating these challenging cancer types. The main therapeutic indication is for various forms of cancer that are difficult to treat with standard therapies. The mechanism of action involves targeting specific molecular pathways that are involved in cancer cell growth and survival, thereby inhibiting tumor progression. It is classified pharmacologically as a targeted anti-cancer therapy, focusing on precise molecular targets within cancer cells.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. It can develop in almost any part of the body and may form a mass called a tumor, although not all cancers form tumors. As cancer progresses, it can invade nearby tissues and spread to other parts of the body through the blood and lymph systems. The progression of cancer varies depending on the type and location, with some cancers growing slowly and others rapidly. Symptoms can include lumps, unexplained weight loss, fatigue, and changes in skin appearance, among others. The course of the disease can be influenced by factors such as genetics, lifestyle, and environmental exposures.