Conditions: Thyroid Cancer
Keywords: medullary thyroid cancer metastatic thyroid cancer carcinoma of the thyroid receptor tyrosine kinase inhibitor VEGFR Unresectable locally advanced thyroid cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 81
Healthy volunteers: no

Brief summary:
The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.

Detailed description:
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: 300mg vandetanib intervention 2: 150mg vandetanib
Intervention descriptions: intervention 1: Oral blinded tablets taken once daily.

At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment

Dosing with unblinded study treatment can continue until 24 months after patient was randomised.

At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (200mg/day). Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur. intervention 2: Oral blinded tablets taken once daily.

At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment. Patients who have not dose reduced at the time of unblinding may have their dose increased to 300mg

Dosing with unblinded study treatment can continue until 24 months after patient was randomised

At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (100mg/day) \[OR 300 reduced to 200mg/day if dose was increased at unblinding.\] Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur.

Protocol document: