A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase 3 Study to Assess the Efficacy and Safety of Vandetanib 300 mg in Patients With Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy.

AstraZeneca0 个研究点开始时间: 2013年11月7日最近更新: 2023年10月17日

适应症

试验速览

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•Provision of informed consent to participate in the study as well as provision of informed consent to provide a sample of a previously obtained archival tumour biopsy.
•- Female or male aged 18 years and older with previously confirmed histological diagnosis of locally advanced or metastatic differentiated (excluding minimally invasive follicular) thyroid cancer not amenable to surgical resection, external beam radiotherapy or local therapy.
•- Measurable disease defined as at least one lesion, not irradiated within 12 weeks of the date of randomisation, that can be accurately measured at baseline.
•- Patients must have progression and be RAI-refractory/resistant or unsuitable for RAI.
•- TSH suppression below 0.5 mU/L is required.

•- Risk of prolonged QTc as defined by history of QT prolongation; current therapy with any medication known to be associated with Torsades de Pointes or prolongation of QT; congenital long QT syndrome.
•- Previous therapy with approved or investigational tyrosine kinase or anti-VEGF receptor inhibitors or targeted therapies (e.g. multi-targeted kinase inhibitors such as sorafenib, AMG-706, sunitinib, pazopanib, lenvatinib).
•-RAI therapy within 12 weeks prior to first dose of study drug, and radiation therapy other than RAI, including external beam, if not completed prior to randomisation.
•- Inadequate organ function as defined by elevated ALT, AST, ALP or bilirubin; or creatinine clearance <50 ml/min.

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