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Study on Vemurafenib for Patients with Advanced Cancers with BRAF Gene Changes

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 the effects of a medication called vemurafenib, also known by its code names RO5185426 and PLX4032. The study is designed for patients with certain types of cancers that have a specific genetic change known as a BRAF genomic alteration. These cancers include, but are not limited to, non-small cell lung cancer, ovarian cancer, cholangiocarcinoma (a type of bile duct cancer), thyroid cancer, prostate cancer, bladder cancer, sarcoma, gastrointestinal stromal tumors (GIST), multiple myeloma, chronic lymphocytic leukemia (CLL), and hairy cell leukemia (HCL). The purpose of the study is to explore how effective vemurafenib is when used alone to treat these cancers.

Participants in the study will receive vemurafenib in the form of film-coated tablets. The study will monitor the response of the tumors to the medication over a period of time. The main goal is to see if the tumors shrink or stop growing. The study will also look at how long the treatment works, how long patients live without the disease getting worse, and overall survival rates. Additionally, the safety of vemurafenib will be assessed to ensure it is well-tolerated by patients.

This trial is important for understanding how vemurafenib can be used to treat different types of cancers that share the BRAF genomic alteration. By focusing on this specific genetic change, the study aims to provide more targeted treatment options for patients whose cancers are not responding to standard therapies. The results could lead to new ways of managing these cancers and improving patient outcomes.

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
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.
A signed informed consent form is required to participate in the trial.
Step 2
Initial Assessment
An initial assessment is conducted to evaluate the current health status and confirm the presence of BRAF genomic alterations in the tumor.
This includes various tests and evaluations to ensure all eligibility criteria are met.
Step 3
Treatment Administration
The treatment involves taking Zelboraf 240 mg film-coated tablets orally.
The dosage and frequency are determined by the study protocol and the healthcare provider overseeing the trial.
Step 4
Monitoring and Follow-up
Regular monitoring is conducted to assess the response to the treatment and any side effects.
This includes scheduled visits for physical examinations, blood tests, and imaging studies as required by the trial protocol.
Step 5
Completion of Treatment
Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the medication.
Long-term follow-up may be required to monitor health status and any delayed effects of the treatment.

Who can join the trial?

16 criteria

Must be a male or female who is 18 years of age or older.
Must have an ECOG Performance Status of 0 to 2, or a Karnofsky scale score greater than 50%. These are scales used to measure how well a patient can perform daily activities.
Must have a life expectancy of at least 3 months.
If able to have children, must agree to use effective birth control methods or practice complete abstinence during the study and for at least 6 months after the last dose of the study drug.
Women who can have children must have a negative pregnancy test before starting the study drug.
Women who are breastfeeding must stop nursing before starting the study drug and permanently after the last dose.
Must be affiliated with a Social Security System.
Must sign a written informed consent form, indicating understanding and agreement to participate in the study.
Must have a type of cancer that is advanced and cannot be removed by surgery, confirmed by a test called histology, and is resistant to standard treatments or for which no standard treatment exists. This excludes a specific type of skin cancer mutation called melanoma V600.
Must have a specific genetic change called the BRAF V600 mutation in certain types of cancer, such as lung, ovarian, bile duct, thyroid, prostate, bladder, sarcoma, multiple myeloma, chronic lymphocytic leukemia, or hairy cell leukemia.
Must have measurable disease according to specific guidelines for solid tumors or blood cancers.
If previously treated with cancer drugs or radiation, must have recovered from any side effects and have a break of at least 3 weeks from the last treatment.
If previously treated with an investigational drug, must have a break of at least 4 weeks or a period equal to 5 times the drug's half-life, whichever is longer.
Must have adequate blood, kidney, and liver function as shown by specific laboratory tests.
Must have normal levels of calcium, magnesium, and potassium in the blood.
Must be able to swallow and retain oral medication, which means taking a tablet that cannot be chewed or crushed.

Who cannot join the trial?

3 criteria

Patients who have a type of cancer that has spread to other parts of the body or cannot be removed by surgery.
Patients whose cancer has specific changes in the BRAF gene, which is the target for the drug vemurafenib.
Patients who are not able to receive treatment that could cure their cancer.

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Verified sites

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

Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France
Centre Hospitalier Departemental Vendee
Verified
La Roche sur Yon, France
Centre Hospitalier Regional Et Universitaire De Brest
Verified
Brest, France

Trial locations

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Investigated drugs

Vemurafenib is a medication used in this clinical trial to treat patients with tumors that have specific changes in the BRAF gene. The trial aims to see how effective vemurafenib is when used alone in treating different types of tumors that have these genetic alterations.

Vemurafenib

What is already known about the treatment

Vemurafenib – Vemurafenib is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating patients with metastatic or locally advanced cancers that have specific BRAF genetic changes. It is primarily used for patients who cannot undergo curative treatment. The medication works by targeting and inhibiting the BRAF protein, which is involved in cell growth and division, thereby slowing down or stopping the growth of cancer cells. Vemurafenib is classified as a BRAF inhibitor, a type of targeted cancer therapy.

Investigated diseases

Metastatic Cancer
This is a type of cancer that has spread from its original site to other parts of the body. It occurs when cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system to form new tumors in other organs or tissues. The progression of metastatic cancer can vary depending on the type of cancer and the organs affected. It often involves multiple organs and can lead to complex symptoms. The spread of cancer cells can make the disease more challenging to manage. Metastatic cancer is typically considered advanced and requires specialized care.
Locally Advanced Cancer
This refers to cancer that has spread from its original site to nearby tissues or lymph nodes but not to distant parts of the body. It is more extensive than early-stage cancer but has not yet metastasized. The progression involves the growth of the tumor into surrounding structures, which can affect the function of nearby organs. This stage of cancer may cause symptoms related to the pressure or invasion of nearby tissues. Locally advanced cancer can be challenging to treat due to its size and location. It often requires a combination of therapies to manage the disease effectively.