drugset / Trial / NCT05182931
A Prospective, Multi-Centre Trial of TKI Redifferentiation Therapy in Patients With RAIR Thyroid Cancer (I-FIRST Study)
Phase 2
Unknown
80 enrolled
Olivia Newton-John Cancer Research Institute
Austin Health · collabEastern Health · collabMonash Health · collabPeter MacCallum Cancer Centre, Australia · collabRoyal Adelaide Hospital · collabRoyal Brisbane and Women's Hospital · collabRoyal North Shore Hospital · collabSir Charles Gairdner Hospital · collabThe Alfred · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This prospective, multi-centre, open label, non-randomised phase II trial aims restore radioiodine sensitivity in patients with NRAS or BRAFV600E mutant refractory thyroid cancer. Participants will be treated with Trametinib +/- Dabrafenib tyrosine kinase inhibitors for a period of 30 days, restoration of sensitivity will be monitored using 18F-FDG-PET \& I-124 PET imaging.
Timeline
- Start
- 2022-07-14
- Primary completion
- 2024-12-30
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabrafenib | Small molecule | 150 mg | Oral |
| Subject | Trametinib | Small molecule | 2 mg | Oral |