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Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Start date: Aug 22, 2024 to Dec 27, 2024 Show 5 more changesShow less
    • Trial sites expanded: 303 → 307 locations
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints revised (5)
    • Study description shortened, about 1 word
    • Collaborators shortened, about 4 words
  2. Minor Study sites: 301 to 303v12
  3. Minor Site details revised at 1 of 301 sitesv11
  4. Minor Trial sites expanded: 112 → 301 locationsv10
  5. Minor 7 versions Re-verified since Oct 15, 2025, no change to tracked fieldsv3-v9
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 112
    • Start date changed from estimate of Sep 13, 2024 to Aug 22, 2024
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment (refractory) and which expresses a BRAF V600E mutation. Cabozantinib is in a class of medications called receptor tyrosine kinase inhibitors. It binds to and blocks the action of several enzymes which are often over-expressed in a variety of tumor cell types. This may help stop or slow the growth of tumor cells and blood vessels the tumor needs to survive. Dabrafenib is an enzyme inhibitor that binds to and inhibits the activity of a protein called B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. Trametinib is also an enzyme inhibitor. It binds to and inhibits the activity of proteins called MEK 1 and 2, which play a key role in activating pathways that regulate cell growth. This may inhibit the growth of tumor cells mediated by these pathways. The usual approach for patients with thyroid cancer is targeted therapy with dabrafenib and trametinib. This trial may help researchers decide which treatment option (cabozantinib alone or dabrafenib in combination with trametinib) is safer and/or more effective in treating patients with refractory BRAF V600E-mutated differentiated thyroid cancer.
Trial Details
NCT Number NCT06475989
Lead Sponsor ECOG-ACRIN Cancer Research Group
Conditions
(from sponsor)
Refractory Differentiated Thyroid Gland Carcinoma
Enrollment 264 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov