Study of dabrafenib and trametinib combination therapy before and after surgery in patients with BRAF-mutated anaplastic thyroid cancer

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What is this study about?

This study focuses on Anaplastic Thyroid Cancer, which is an aggressive form of thyroid cancer. The treatment being tested combines two medications: dabrafenib and trametinib. These medications are targeted therapies that work together to fight cancer cells in patients who have a specific genetic change called BRAF mutation in their tumor.

The purpose of this research is to determine if giving these medications before surgery can help more patients have successful tumor removal. The treatment plan involves taking both medications by mouth daily. Dabrafenib is taken at a dose of up to 300 mg per day, while trametinib is taken at a dose of up to 2 mg per day. The treatment period may last up to 12 months.

During the study, patients will receive the medications before their planned surgery to help shrink the tumor. After the surgery, patients will continue to take the medications to help prevent the cancer from returning. Throughout the treatment period, doctors will monitor the patients’ health and how well the medications are working.

1 Initial treatment phase

You will receive two medications: dabrafenib and trametinib. Both medications are taken by mouth in pill form.

This treatment phase is called neo-adjuvant therapy, which means treatment given before the main surgery.

Regular blood tests will monitor your health during treatment.

2 Medical evaluations

Your doctor will perform regular examinations to check how your thyroid cancer responds to the treatment.

Imaging tests will be conducted to monitor the size of the tumor.

Side effects will be monitored and documented according to standardized criteria.

3 Surgery phase

After the initial treatment period, you will undergo surgery to remove the thyroid tumor.

The goal is to achieve complete removal of the tumor.

Your recovery will be monitored for 30 days after surgery to check for any complications.

4 Post-surgery treatment

After recovery from surgery, you will continue taking dabrafenib and trametinib.

This phase is called adjuvant therapy, which means treatment given after surgery.

Regular follow-up visits will monitor your recovery and response to treatment.

5 Long-term monitoring

Your progress will be monitored through regular check-ups.

Imaging tests will be performed to check for any signs of cancer return.

The study continues until November 2027.

Who Can Join the Study?

Must be over 18 years old
Must provide informed consent to participate in the study
Must have confirmed thyroid cancer verified through tissue examination
Must have a specific genetic mutation called BRAFV600E/K in the tumor tissue
Must not have cancer that has spread to distant parts of the body
Must have good physical function status (WHO Performance Status 0 or 1, meaning able to perform daily activities)
Must not have received any previous cancer treatments including:
- Chemotherapy
- Immunotherapy
- Radiation therapy
- Other systemic treatments
Must have completed required imaging tests:
- PET-CT scan
- CT scans of neck, chest, and abdomen
Must be able to swallow pills
Must have clear or protected airways
Must have acceptable blood test results, including:
- Blood cell counts
- Liver function tests
- Kidney function tests
- Blood clotting tests
Must not have other severe or uncontrolled medical conditions

Who Cannot Join the Study?

Prior treatment with BRAF or MEK inhibitors (medications that target specific proteins involved in cancer growth)
Previous cancer treatments within the last 14 days before starting the study medication
Presence of other types of cancer besides anaplastic thyroid cancer
Severe heart conditions, including:
- Uncontrolled high blood pressure
- Recent heart attack
- Unstable heart rhythm problems
Severe liver problems or abnormal liver function tests
Pregnancy or breastfeeding
Unable to swallow oral medications
Known allergies to the study medications or their components
Participation in another clinical trial within 30 days before this study
Any medical condition that could interfere with the study treatment or affect patient safety
Mental health conditions that would prevent understanding or following study requirements

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Lsbme Uqmltawtmpxz Mrbijic Cculedf (wmchy	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.07.2022

Trial locations

Investigated drugs:

Based on the provided trial information, this study involves targeted therapy medications commonly used for BRAF-mutated thyroid cancer:

Dabrafenib is a BRAF inhibitor medication that works by blocking a specific protein (BRAF) that is abnormal in some thyroid cancers. It helps to slow down or stop cancer cell growth.

Trametinib is a MEK inhibitor that works together with dabrafenib. It blocks a different protein in the same pathway that helps cancer cells grow. When used together with dabrafenib, it can make the treatment more effective and help prevent resistance to therapy.

Note: These medications are typically used in combination as a targeted therapy approach for BRAF-mutated thyroid cancers, specifically in this case for anaplastic thyroid cancer before and after surgery.

Investigated diseases:

Anaplastic thyroid cancer

Anaplastic Thyroid Cancer – A rare and aggressive form of thyroid cancer that develops in the thyroid gland located in the front of the neck. The disease begins when healthy thyroid cells change and grow out of control, forming a mass called a tumor. This type of cancer can spread rapidly to surrounding tissues in the neck and to other parts of the body. The condition affects the thyroid’s ability to produce hormones that help regulate many vital functions in the body. Unlike other thyroid cancers, anaplastic thyroid cancer typically occurs in older adults and changes the shape and function of thyroid cells more dramatically.

Trial ID:

2024-516126-54-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of dabrafenib and trametinib combination therapy before and after surgery in patients with BRAF-mutated anaplastic thyroid cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?