RecruitingPhase 2NCT06362694

Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy

Sponsor

Saint Petersburg State University, Russia

Enrollment

10 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Anaplastic Thyroid Cancer

Summary

This pilot phase 2 study evaluates the effectiveness and safety of the Rechallenge concept in patients with BRAF-positive anaplastic thyroid cancer after progression on anti-BRAF therapy. Patients with BRAF-positive anaplastic thyroid cancer who were previously treated with dabrafenib and trametinib (with a clinical or objective response at the start of treatment) and later with tumor progression during anti-BRAF therapy and subsequent lines of chemotherapy are scheduled to undergo targeted therapy (repeated administration of dabrafenib and trametinib in standard doses) and evaluate the outcomes according to the primary and secondary endpoints.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at restarting a targeted therapy combination (dabrafenib + trametinib) in patients with a rare and aggressive type of thyroid cancer (anaplastic thyroid cancer) that has a specific BRAF gene mutation, after they previously responded to this treatment but later progressed. **You may be eligible if...** - You have confirmed anaplastic thyroid cancer - Your cancer has the BRAF V600 gene mutation - Your cancer progressed after treatment with dabrafenib and trametinib - Your cancer progressed after at least one chemotherapy regimen that included taxane drugs - You are 18 or older and in reasonable physical condition (ECOG 0–2) - You have adequate organ and bone marrow function **You may NOT be eligible if...** - You never responded to dabrafenib and trametinib in the first place - You have not received taxane-based chemotherapy - You have not met other organ function requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDabrafenib + Trametinib

Dabrafenib is an inhibitor of some mutated forms of BRAF kinases. Trametinib is a reversible inhibitor of mitogen-activated extracellular signal-regulated kinase 1 (MEK1) and MEK2 activation and of MEK1 and MEK2 kinase activity. Dabrafenib and trametinib target two different kinases in the RAS/RAF/MEK/ERK pathway. Use of dabrafenib 623 and trametinib in combination resulted in greater growth inhibition of BRAF V600 mutation-positive tumors.