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Study on the Effectiveness and Safety of Plixorafenib (FORE8394) for Patients with Cancer Having BRAF Alterations

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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 certain types of cancer that have changes in a gene called BRAF. These changes are known as BRAF alterations. The trial is testing a new treatment called Plixorafenib, also known by its code name FORE8394. This treatment is designed to target and inhibit specific changes in the BRAF gene, which are found in some cancers. The purpose of the study is to evaluate how effective and safe Plixorafenib is for patients with these specific genetic changes in their cancer.

The study involves two main groups of participants. The first group includes individuals with advanced or spreading solid tumors or certain brain tumors that have a specific type of BRAF change called a BRAF fusion. The second group includes individuals with a type of brain tumor known as high-grade glioma that has a different BRAF change called the BRAF V600E mutation. Participants in the study will receive the treatment in the form of tablets taken by mouth. The study will last for a period of up to 120 days, during which the effects of the treatment will be closely monitored.

Throughout the study, participants will be assessed to determine how well the treatment is working and to monitor any side effects. The study aims to gather information on the treatment's impact on the cancer and its safety profile. This information will help researchers understand the potential benefits and risks of using Plixorafenib for treating cancers with BRAF alterations.

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, such as age, weight, and medical history related to BRAF alterations in tumors.
Participants are assigned to either Subprotocol A or Subprotocol B, depending on their specific medical condition and tumor characteristics.
Step 2
Initial assessment
An initial assessment is conducted to gather baseline data. This includes providing tissue samples for testing and undergoing scans to evaluate the tumor's current state.
Participants may need to provide archival tissue samples or undergo a fresh biopsy if necessary.
Step 3
Treatment administration
Participants receive the study medication, Plixorafenib (FORE8394), which is an inhibitor targeting BRAF alterations.
The medication is administered orally in the form of film-coated tablets. The dosage and frequency are determined by the study protocol and the participant's specific condition.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the efficacy and safety of the treatment. This includes periodic scans and laboratory tests to track changes in the tumor and overall health.
Participants are required to report any side effects or changes in their condition to the study team.
Step 5
Evaluation of outcomes
The primary outcome is measured by the overall response rate (ORR) using specific criteria based on the type of tumor.
Secondary outcomes include duration of response (DOR), progression-free survival (PFS), and overall survival (OS), among others.
Step 6
Completion of the study
The study is estimated to conclude by December 31, 2027. Participants will have a final assessment to evaluate the long-term effects of the treatment.
Data collected throughout the study will contribute to understanding the efficacy and safety of Plixorafenib in treating tumors with BRAF alterations.

Who can join the trial?

10 criteria

Participants must be male or female, at least 10 years old, and weigh at least 30 kg.
For Subprotocol A, participants need a confirmed diagnosis of a solid tumor or a primary central nervous system (CNS) tumor.
For Subprotocol B, participants need a confirmed diagnosis of a primary CNS tumor, which includes various types of brain tumors.
Participants must have a specific change in the BRAF gene, detected through a validated test.
Participants must provide a tissue sample from a previous biopsy for testing, or a new biopsy if the previous sample is unavailable.
Participants must have measurable disease, meaning the tumor can be measured using imaging techniques.
Participants must have completed all available standard treatments, or be unable to tolerate them, or the doctor must decide that standard treatments are not suitable.
Any side effects from previous treatments must have improved to a mild level, except for hair loss or mild nerve damage, which are acceptable.
Participants taking corticosteroids, a type of medication, must be on a stable or decreasing dose for at least 7 days before starting the study treatment.
Participants must agree to provide previous scans to help assess changes in the tumor over time.

Who cannot join the trial?

10 criteria

Patients who have a different type of tumor that does not have changes in the BRAF gene. The BRAF gene is a part of your DNA that can affect how cells grow.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or take the study medication 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, as the study medication might affect the baby.
Patients who are currently participating in another clinical trial or have recently taken part in one.
Patients who have had a recent major surgery or are recovering from one.
Patients who have a history of certain heart problems, as the study medication might affect the heart.
Patients who have an active infection that requires treatment.
Patients who have a known allergy to the study medication or any of its ingredients.

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Verified sites

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

Centre Hospitalier Regional Et Universitaire De Brest
Verified
Brest, France
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

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Investigated drugs

Plixorafenib (FORE8394) is a medication being studied for its effectiveness and safety in treating certain types of cancer. It is designed to target and inhibit specific alterations in the BRAF gene, which can be involved in the growth of cancer cells. This trial is exploring how well Plixorafenib works in patients with different types of tumors that have these BRAF alterations, including solid tumors and certain brain tumors. The study aims to understand how the medication affects the body and how it can be used to treat cancers with these specific genetic changes.

What is already known about the treatment

Plixorafenib – Plixorafenib is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating cancers with specific BRAF gene alterations. It is primarily indicated for patients with locally advanced or metastatic solid tumors, as well as recurrent or progressive primary central nervous system tumors that have BRAF fusions, and for those with recurrent high-grade gliomas with the BRAF V600E mutation. The medication works by inhibiting the activity of BRAF proteins, which are involved in cell growth and division, thereby potentially slowing or stopping the growth of cancer cells. Plixorafenib is classified as a targeted cancer therapy, specifically a BRAF inhibitor.

Investigated diseases

Tumors harboring BRAF alterations – These are a group of tumors characterized by changes in the BRAF gene, which is involved in cell growth. Such alterations can lead to uncontrolled cell division and tumor development. Tumors with BRAF alterations can occur in various parts of the body, including the skin, thyroid, and brain. The progression of these tumors depends on the specific type and location, but they often grow and spread more rapidly than tumors without such genetic changes. BRAF alterations are commonly associated with certain types of melanoma and other cancers. Understanding the specific BRAF mutation can help in determining the behavior and potential treatment strategies for these tumors.