Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Study ID
- NCT03244956
- Phase
- PHASE2
- Status
- Completed
Conditions
- Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Trametinib — DRUG2mg daily for a maximum of 6 weeks of treatment
- Dabrafenib — DRUG150mg twice daily
- 131I — RADIATION5.5 GBq
- rhTSH — DRUG0.9mg on two consecutive days after 35 days of treatment
Study Details
This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation.
Key Dates
- Start date
- Dec 27, 2017
- Status verified
- Mar 2026
- Primary completion
- May 23, 2022
- Completion
- Jan 15, 2026
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: patients with RAS mutation
- Experimental: patients with BRAFV600E mutation
Primary Outcome Measure
Objective Response Rate (ORR) [ Time Frame: Evaluated 6 months after the first dose of trametinib or trametinib and dabrafenib followed by RAI treatment in each arms ]