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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of the rechallenge concept in patients with BRAF-positive anaplastic thyroid cancer who have experienced tumor progression after initial anti-BRAF therapy. This pilot phase 2, prospective, open-label study focuses on patients previously treated with dabrafenib and trametinib who showed an initial clinical or objective response but later developed progression during anti-BRAF treatment and subsequent chemotherapy, including mandatory taxane regimens. The investigational treatment involves repeated administration of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) at standard doses. Treatment continues until disease progression or intolerable toxicity occurs. The study includes an initial 10-day treatment followed by imaging assessment, ongoing targeted therapy for responders, and monitoring of patient survival and safety during treatment and up to 90 days post final dose. Participants undergo clinical and laboratory evaluations, including computed tomography scans of the brain, neck, chest, and abdomen with intravenous contrast at baseline and at follow-up intervals. Tumor mutations such as BRAF V600, microsatellite instability, and PD-L1 expression are assessed, along with optional genetic variants. Response to treatment is evaluated by RECIST 1.1 criteria, with safety monitored throughout the study and post-treatment periods. The total duration of follow-up may extend up to 48 months for some outcome measures.
CONDITIONS
Brief 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 use of taxane-containing chemotherapy as second or third line treatment
- Contraindication to study drugs including severe prior toxicity leading to treatment discontinuation
- ECOG performance status of 3 or 4
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until progression or intolerable toxicity
Participants receive targeted therapy with dabrafenib and trametinib until disease progression or intolerable toxicity.
Visits every 21 days for safety assessments; imaging assessments at 10 days and monthly thereafter
Duration - Up to 90 days after the final dose if no further antitumor treatment is given
Participants are monitored for survival and safety after treatment ends, including documentation of subsequent antitumor treatments.
Visits at 30 and 90 days after treatment ends for safety monitoring
Trial Site Locations
Total: 1 location
1
Saint Petersburg State University Hospital
Saint Petersburg, Russia, 190020
Actively Recruiting
Research Team
I
Ilya Sleptsov, MD
E
Ernest Dzhelialov
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here