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New treatment option for Anaplastic Thyroid Cancer
Official title NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)
ClinicalTrials.gov ID: NCT06079333
What this study is testing
What is dabrafenib/trametinib?
dabrafenib/trametinib is an investigational medicine, being studied as a potential treatment for anaplastic thyroid cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Anaplastic thyroid cancer (ATC) is an almost invariable lethal cancer in humans. Most patients present with a rapid progressive mass in the neck with progressive complaints like dyspnoea, dysphagia or pain.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed consent.
- Age over 18 years old.
- World Health Organization (WHO) Performance Status 0 or I.
- Histologically confirmed ATC (centrally reviewed).
- Confirmed presence of BRAFV600E/K mutation in primary tumor tissue.
You likely can't join if
- No informed consent.
- History of cancer within 2 years from diagnosis of ATC (exception: basal cell skin cancer, in situ carcinoma).
- Poorly differentiated transformation of previous differentiated thyroid cancer.
- Presence of distant metastases.
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the...
- History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes, significant arrhythmias and severe valvular...
See the full eligibility criteria
- Informed consent.
- Age over 18 years old.
- World Health Organization (WHO) Performance Status 0 or I.
- Histologically confirmed ATC (centrally reviewed).
- Confirmed presence of BRAFV600E/K mutation in primary tumor tissue.
- No distant metastases (M0).
- Free or secured airway.
- Able to swallow pills.
- Patients must have undergone complete disease staging including: PET-CT scan and CT-neck/thorax/abdomen.
- No prior anticancer systemic treatment (including chemotherapy, immunotherapy, oncolytic viral therapy, other systemic therapies).
- No prior radiotherapy to site of interest.
- Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥ 1.0x109/L, Platelets ≥ 100 x109/L, Hemoglobin ≥ 6.5 mmol/L, AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR...
- Absence of additional severe and/or uncontrolled concurrent disease.
- No informed consent.
- History of cancer within 2 years from diagnosis of ATC (exception: basal cell skin cancer, in situ carcinoma).
- Poorly differentiated transformation of previous differentiated thyroid cancer.
- Presence of distant metastases.
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events
- History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
- Pregnancy or nursing.
The study team makes the final eligibility decision.
Where it's taking place
- Leiden, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leiden, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.