Study on Treating Advanced Cancers with BRAF Mutations Using Sorafenib and Trametinib for Patients with Impaired Kinase Activity

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What is this study about?

This clinical trial is focused on studying advanced-stage cancers that have a specific change in their genes known as BRAF mutations. These mutations affect how certain proteins work in the body. The study is testing a combination of two medications: Sorafenib and Trametinib. Sorafenib is also known by the brand name Nexavar, and Trametinib is known as Mekinist or by its code name GSK1120212B. Both medications are taken as film-coated tablets by mouth.

The purpose of the study is to find the best dose of these medications when used together. Participants will receive both Sorafenib and Trametinib to see how their cancer responds to the treatment. The study will monitor how well the treatment works and any side effects that may occur. The trial will continue until the researchers determine the most effective and safe dose for future studies.

Participants in the study will have regular check-ups and tests, such as MRI or CT scans, to measure the size of their cancer and assess their overall health. The study aims to provide valuable information that could lead to better treatment options for people with cancers that have BRAF mutations.

1 joining the study

Upon joining the study, the patient must have a confirmed diagnosis of advanced-stage malignancies with BRAF mutations that affect kinase activity.

The patient must have experienced progression after standard treatment and have at least one measurable lesion.

2 initial assessment

The patient undergoes an initial assessment to confirm eligibility, including tests to ensure adequate liver and kidney function.

The patient must be able to swallow and retain oral medication.

3 medication administration

The patient receives Mekinist (trametinib) 0.5 mg and Nexavar (sorafenib) 200 mg, both in the form of film-coated tablets.

Both medications are taken orally. The specific dosage and frequency are determined based on the trial’s phase and the patient’s response.

4 monitoring and follow-up

The patient is monitored regularly for any side effects or adverse events. This includes both common and serious adverse events.

The patient’s disease control rate is assessed using imaging techniques like CT, PET-CT, or MRI.

5 trial completion

The trial aims to determine the maximum tolerated dose of the medication combination and the recommended dose for further study phases.

The estimated end date for the trial is September 30, 2027.

Who Can Join the Study?

Patients must be 18 years or older. There is no upper age limit.
Patients must have a metastatic malignancy, which means cancer that has spread to other parts of the body.
Patients must have experienced progression after standard treatment, meaning their cancer has continued to grow or spread despite usual treatments.
Patients must have a BRAF mutation with impaired kinase activity. This is a specific change in the cancer’s genetic material that affects how the cancer grows.
Patients must have a BRAF mutation that is sensitive to sorafenib, a type of cancer medication, as determined by laboratory tests.
Patients must have at least one lesion (an area of abnormal tissue) that can be measured using imaging tests like CT, PET-CT, or MRI.
Patients must have adequate liver function, which means their liver is working well enough, with specific blood test results for AST, ALT, and bilirubin within certain limits.
Patients must have a calculated creatinine clearance of at least 50 mL/min. This is a measure of how well the kidneys are working.
Patients must be able to swallow and retain oral medication and should not have significant digestive issues that could affect how the medicine is absorbed.
Patients must provide written informed consent, which means they agree to participate in the study after being fully informed about it.
Patients must be able to understand the nature of the trial and follow the trial procedures.

Who Cannot Join the Study?

Patients who do not have advanced-stage cancer with specific genetic changes called BRAF mutations.
Patients who are not within the specified age range for the trial.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who cannot tolerate the combination of the drugs trametinib and sorafenib.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Medizinische Hochschule Hannover	Hanover	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	21.10.2020

Trial locations

Investigated drugs:

Trametinib is a medication used in this trial to inhibit a protein called MEK, which is involved in the growth and spread of cancer cells. By blocking this protein, trametinib may help slow down or stop the progression of certain types of cancer.

Sorafenib is another medication used in the trial that works by blocking certain proteins that promote cancer cell growth. It targets multiple pathways that cancer cells use to grow and spread, potentially helping to control the disease.

Investigated diseases:

BRAF gene mutation

Advanced-Stage Malignancies with BRAF Mutations – These are cancers that have progressed to an advanced stage and contain specific mutations in the BRAF gene, which affect the kinase activity within cells. The BRAF gene is involved in cell growth, and mutations can lead to uncontrolled cell division. These malignancies can occur in various parts of the body, including the skin, thyroid, and colon. The presence of BRAF mutations often indicates a more aggressive form of cancer. As the disease progresses, it may spread to other parts of the body, complicating treatment and management. Understanding the specific mutation type is crucial for determining appropriate therapeutic strategies.

Trial ID:

2024-512887-77-00

Protocol code:

1056 SORATRAM

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Treating Advanced Cancers with BRAF Mutations Using Sorafenib and Trametinib for Patients with Impaired Kinase Activity

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?