NCT03244956

Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer

Efficacy of a Selective MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors Associated With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer With RAS or BRAFV600E Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-12-27
• Primary completion: 2022-05-23
• Completion: 2026-01-15
• First posted: 2017-08-10
• Last updated: 2026-03-23

Locations

1 site across 1 country: France