CompletedPhase 2

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

France40 participantsStarted 2017-12-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Distant metastasis without radioiodine uptake on a posttherapeutic radioactive scan
✓. Distant metastasis disclosing RECIST progression within 12 months after a RAI treatment
✓. Absolute neutrophil count (ANC) ≥1.5 x 109/L
✓. Hemoglobin ≥9.0 g/dL
✓. Platelet count ≥100 x 109/L
✓. Normal blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5
✓. Bilirubin ≤1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome,
✓. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver metastases).

What they're measuring

Objective Response Rate (ORR)

Timeframe: Evaluated 6 months after the first dose of trametinib or trametinib and dabrafenib followed by RAI treatment in each arms

Trial details

NCT IDNCT03244956

SponsorGustave Roussy, Cancer Campus, Grand Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-23

View on ClinicalTrials.gov More Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation trials