Cabozantinib In Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer.

Sponsor
Grupo Espanol de Tumores Neuroendocrinos
Study ID
NCT05660954
Phase
PHASE2
Status
Completed

Conditions

  • Differentiated Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    * All enrolled patients will receive cabozantinib at a fixed dose of 60 mg once a day (QD). Patients will continue study treatment until PD (either clinical or radiological), or until unacceptable toxicity, the need for another systemic anticancer treatment, or other reasons for treatment discontinuation. * Patients will take the tablet(s) once daily at bed time except for Week 1 Day 1: the first dose of study treatment will be administered in the clinic so that each patient can be observed for initial tolerability. Subsequent doses will be self-administered at home. The tablets should be swallowed whole and not crushed and administered fasting for at least 2 hours before through 1 hour after. If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.

Study Details

CABOTHYROID is a prospective, exploratory, biomarker-focused, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study of cabozantinib in patients with previously treated advanced radioactive-iodine refractory

Key Dates

Start date
May 25, 2023
Status verified
Apr 2026
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib, 60 mg
    Patients with advanced radioactive-iodine refractory DTC who progressed to previous TKIs (including but not limited to lenvatinib or sunitinib). Patients will have not received previously cabozantinib, selective small-molecule BRAF kinase inhibitors, immune checkpoint inhibitor therapy, or systemic chemotherapy regimens.

Primary Outcome Measure

Gene expression of molecular biomarkers characteristics of the pathology [ Time Frame: Time point: At baseline, before any dose of study treatment ]

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