Cabozantinib In Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer.
Spain41 participantsStarted 2023-05-25
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female subjects ≥ 18 years old.
✓. Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities.
✓. Histologically or cytologically confirmed diagnosis of DTC, including the following subtypes:
✓. Papillary thyroid carcinoma (PTC) including histological variants of PTC such as follicular variant, tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma, poorly differentiated.
✓. Follicular thyroid carcinoma (FTC) including histological variants of FTC such as Hürthle cell, clear cell, insular, and poorly differentiated.
✓. Measurable disease according to RECIST 1.1 on computed tomography/magnetic resonance imaging (CT/MRI) performed within 28 days prior to first dose of study treatment.
✓. Must have been previously treated with or deemed ineligible for treatment with Iodine-131 for DTC.
✓. Must have been previously treated and experienced documented radiographic progression per RECIST 1.1 with one or two of the following vascular endothelial growth factor (VEGF) targeting TKI agents for DTC:
Exclusion criteria
✕. Prior treatment with any of the following:
✕. Cabozantinib.
✕
What they're measuring
1
Gene expression of molecular biomarkers characteristics of the pathology
Timeframe: Time point: At baseline, before any dose of study treatment
2
Gene expression of molecular biomarkers characteristics of the pathology
Timeframe: Time point: Throughout the study period, approximately 2 years per patient
✕. Systemic chemotherapy regimen (given as a single agent or in combination with another chemotherapy agent).
✕. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before first dose of study treatment.
✕. Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before first dose of study treatment.
✕. Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Patients with clinically relevant ongoing complications from prior radiation therapy that have not completely resolved are not eligible (eg, radiation esophagitis or other inflammation of the viscera).