Actively Recruiting
Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy
Led by Saint Petersburg State University, Russia · Updated on 2024-04-12
10
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Immunohistochemically confirmed anaplastic thyroid cancer
- Presence of a mutation in the BRAF V600 gene
- Documented progression during targeted therapy with dabrafenib and trametinib
- Documented progression during at least one line of chemotherapy including taxane-containing regimens
- Age 18 years or older
- ECOG performance status between 0 and 2
- Adequate function of internal organs and bone marrow
- Ability to provide written informed consent
You will not qualify if you...
- Primary resistance to dabrafenib and trametinib (no initial clinical or radiological response and response duration less than 3 months)
- No prior taxane-containing chemotherapy as second or third line treatment
- Contraindications to study drugs, including severe toxicity causing treatment discontinuation
- ECOG performance status of 3 or 4
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Saint Petersburg State University Hospital
Saint Petersburg, Russia, 190020
Actively Recruiting
Research Team
I
Ilya Sleptsov, MD
CONTACT
E
Ernest Dzhelialov
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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