Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer
NCT03244956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-03-23
Summary
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.
Conditions
- Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation
Interventions
- DRUG
-
Trametinib
2mg daily for a maximum of 6 weeks of treatment
- DRUG
-
Dabrafenib
150mg twice daily
- RADIATION
-
131I
5.5 GBq
- DRUG
-
rhTSH
0.9mg on two consecutive days after 35 days of treatment
Sponsors & Collaborators
-
Gustave Roussy, Cancer Campus, Grand Paris
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-27
- Primary Completion
- 2022-05-23
- Completion
- 2026-01-15
Countries
- France
Study Locations
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