VERIFY

JRCT ID: jRCT2080222283

Registered date:07/11/2013

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Differentiated Thyroid Cancer
• Date of first enrollment: 07/11/2013
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : vandetanib
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 300 mg (3 x 100 mg tablets) will be dosed orally, once daily

control material(s)
Generic name etc : placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Placebo(3 tablets) will be dosed orally, once daily

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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.

Exclude criteria

- 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.

Related Information

• Primary Sponsor: AstraZeneca
• Secondary ID(s): JapicCTI-132332