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Vandetanib · VERIFY

Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer

Ensayo de Sanofi en Differentiated Thyroid Cancer (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

238

previstos

Centros

61

Fin del objetivo primario

ago 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en sep 2013.

Qué mide

Progression-Free Survival (PFS) (Randomization until disease progression or death, assessed every 12 weeks (up to 22 months)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To determine the efficacy (as assessed by progression-free survival \[PFS\]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy. Secondary Objectives: * To determine the efficacy of vandetanib when compared to placebo in this participant population as assessed by efficacy variables including duration of response (DOR), objective response rate (ORR), change in tumour size (TS) and overall survival (OS). * To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and potentially investigate any influence of participant demography and pathophysiology on vandetanib PK. * To demonstrate an improvement in time to worsening of pain (TWP) in participants treated with vandetanib when compared to placebo in this participant population. * To evaluate the safety and tolerability of vandetanib treatment in this participant population.

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Ficha completa en ClinicalTrials.gov (NCT01876784), actualizada en jun 2024.