NCT04619316

Enhancing Radioiodine Incorporation Into Radio Iodine Refractory Thyroid Cancers With MAPK Inhibition

Enhancing Radioiodine Incorporation Into Radio Iodine Refractory Thyroid Cancers With MAPK Inhibition: A Single Center Pilot Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective interventional trial that aims to restore iodine incorporation in tumoral lesions of patients with unresectable, radioiodine-refractory thyroid cancer.

Detailed description

This is a prospective interventional study testing the hypothesis that the inhibition of MEK can restore iodine incorporation in BRAF wild type (WT) and a combined inhibition of BRAF and MEK can restore iodine incorporation in BRAFV600E mutant (MUT), radioiodine-refractory (RAIR) thyroid cancer. Patients with proven iodine negative tumor lesion(s) will be included in this study. Patients will then receive Trametinib (WT-group) or Dabrafenib and Trametinib combination-therapy (MUT-group) for approximately 3 weeks, after which a Thyrogen-stimulated 123I SPECT imaging will be performed. For patients whose tumor(s) demonstrate sufficient iodine incorporation in the post drug treatment 123I SPECT imaging, a treatment according to guidelines for iodine positive lesions will be performed. The follow up of the patients will be conducted as standard of care.

Conditions

• Metastatic Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Trametinib 2 MG [Mekinist]	Monotherapy with Trametinib is given in patients with BRAF wildtype.
DRUG	Trametinib 2 MG [Mekinist] and Dabrafenib 75 MG (2-0-2) [Tafinlar]	Combination therapy is given in patients with BRAF V600E mutation.

Timeline

• Start date: 2018-02-05
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-11-06
• Last updated: 2023-06-22

Locations

1 site across 1 country: Germany