A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects With Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03690388Tipo: INTERVENTIONALInicio: 5 de oct de 2018Fin estimado: 31 de jul de 2026

Traducción no disponible, mostrando original

Resumen

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior vascular endothelial growth factor receptor (VEGFR)-Targeted therapy.

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC)
Previously treated with at least one of the following vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Criterios de exclusión

Prior treatment with any of the following: Cabozantinib; Selective small-molecule v-raf murine sarcoma viral oncogene homolog B1 (BRAF) kinase inhibitor; More than 2 VEGFR-targeting TKI agents; More than 1 immune checkpoint inhibitor therapy; 1 systemic chemotherapy regimen (given as 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 randomization
Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization.
Known brain metastases or cranial epidural disease unless adequately treated

Intervenciones

drug

Cabozantinib

Tablets containing 60-mg or 20-mg cabozantinib once daily orally.

drug

Placebo

Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.

Ubicaciones

Exelixis Clinical Site #96

Pergamino, Buenos Aires, Argentina

Exelixis Clinical Site #97

Caba, Argentina

Exelixis Clinical Site #129

Córdoba, Argentina

Patrocinadores

PrincipalExelixis

ColaboradorIpsen

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