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Dabrafenib/Trametinib vs Cabozantinib in RAI-Refractory BRAF V600E-Mutated Differentiated Thyroid Cancer
NCT06475989Phase 3
Key facts
- Status
- Recruiting
- Start
- Dec 2024
- Primary completion
- Sep 2030
- Countries
- 1
- Sponsor
- ECOG-ACRIN Cancer Research Group
- Modality
- Small Molecules
- Drugs
- cabozantinib
- Conditions
- differentiated thyroid cancer (DTC)
01
Overview
Phase 3, randomised, open-label trial of cabozantinib in differentiated thyroid cancer (DTC) (2 arms), sponsored by ECOG-ACRIN Cancer Research Group. Primary endpoint: Progression-Free Survival up to 5 years. Started Dec 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Dabrafenib and trametinib
Dabrafenib PO BID and trametinib PO QD on days 1-28 of each 28-day cycle.
Cabozantinib
Cabozantinib PO QD on days 1-28 of each 28-day cycle.
03
Who it enrols
Patients must have BRAF V600E-mutated differentiated thyroid cancer that progressed on frontline multikinase inhibitor therapy (lenvatinib or sorafenib), be ineligible for or previously treated with Iodine-131, and have adequate organ function.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Objective Response Rate
Overall Survival
Duration of Response
Progression-Free Survival 2
Incidence of Adverse Events
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