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A Prospective, Multi-Centre Trial of TKI Redifferentiation Therapy in Patients With RAIR Thyroid Cancer (I-FIRST Study)

NCT05182931 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-10-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dabrafenib 75 MG

Refer arm description

DRUG

Trametinib 2 MG

Refer arm description

Sponsors & Collaborators

  • Royal North Shore Hospital

    collaborator OTHER

  • Austin Health

    collaborator OTHER_GOV

  • Sir Charles Gairdner Hospital

    collaborator OTHER

  • Monash Health

    collaborator OTHER

  • Peter MacCallum Cancer Centre, Australia

    collaborator OTHER

  • Royal Brisbane and Women's Hospital

    collaborator OTHER_GOV

  • Eastern Health

    collaborator OTHER

  • The Alfred

    collaborator OTHER

  • Royal Adelaide Hospital

    collaborator OTHER

  • Olivia Newton-John Cancer Research Institute

    lead OTHER

Principal Investigators

  • Andrew M Scott, MD, FRACP · Austin Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2024-12-30
Completion
2025-12-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05182931 on ClinicalTrials.gov