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

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Thyroid<br/>CancersCancer LocationThyroid

Systemic therapy | Head and neckThyroid

Trial Overview Read MoreRead more

This phase II trial will use Dabrafenib and/or Trametinib to enhance treatment for people with thyroid cancer who no longer respond to radioactive iodine (a standard treatment for people with this type of cancer).

This trial is treating patients with radioiodine refractory thyroid cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Other Non-Commercial Sponsor

Olivia Newton-John Cancer Research Institute


This is a non-randomised, open-label study for adults with radioiodine refractory differentiated thyroid cancer with BRAF V600E or NRAS mutations. Prior to commencing interventional treatment, participants will commence a low iodine diet and undergo thyroxine withdrawal and commence T3 replacement from day -27. On day -5 they will receive an oral dose of 124I (40MBq/1.08 mCi) with imaging at 24 hours (+/-6) post dose and a second imaging assessment within 120 hours. During Days 1-30, participants with BRAF V600E mutations will then receive Dabrafenib (oral, 150mg twice daily) and Trametinib (oral, 2mg once daily); and participants with RAS mutations will receive Trametinib (oral, 2mg once daily). All participants will then receive a second oral dose of I124 will be administered at day 24 followed by imaging at the same interval as baseline. Participants achieving >20Gy tumour uptake of I124 will be administered 6GBq (3.3Gy/GBq) 131I, I131 wb scan and SPECT/CT will be performed within 24 hours and at hospital discharge. Participants who do not achieve >20Gy tumour update of I-124 will move into follow up. Follow up will occur every 12 weeks for 12 months.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
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Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.