Vandetanib Phase IV study in Metastatic Medullary Thyroid Carcinoma
Research type
Research Study
Full title
An International, Randomised, Double-Blind, Two-Arm Study to Evaluate the Safety and Efficacy of Vandetanib 150 and 300 mg/day in Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma with Progressive or Symptomatic Disease
IRAS ID
101308
Contact name
Maralyn Druce
Sponsor organisation
AstraZeneca AB
Eudract number
2011-004701-24
Clinicaltrials.gov Identifier
Research summary
Vandetanib is approved in USA by the FDA as a treatment for medullary thyroid cancer (MTC) that has spread outside of the thyroid. In a previous clinical trial, patients with advanced MTC who took vandetanib had slower tumour (cancer) growth compared to patients who were taking placebo (a sugar pill). Also, for 45% of patients on vandetanib their tumours became smaller. The FDA has requested this clinical trial to study the effectiveness and safety (side-effects) of two different doses of vandetanib in treating MTC; 300mg/day (the currently approved dose) and 150 mg/day. The main objectives are to understand whether 150mg/day is as effective overall as 300mg/day but with fewer side effects. 80 adult patients who are not suitable for surgical treatment and who have MTC disease that can be measured (with CT or MRI scans) will take part in the study worldwide. Investigators will perform checks to ensure their patients are eligible for the study. The trial consists of 2 parts; in the first part patients will be allocated, by chance, to tablets for either the 300 or 150mg/day dose by computer. The patient, doctor and team running the study will not know which dose has been allocated (double blind). Regular visits will be required to check how the patient is doing and for tests including blood samples, tumour scans, and checks on heart and eye function. The patient stays in this part of the study for 14 months or until their disease has spread (whichever is earlier). After this, the study doctor and patient will be told which dose they were taking. Patients still taking vandetanib 150mg/day may increase to 300mg/day for the rest of the trial (up to 2 years since their first dose). Regular visits continue but disease measurements are no longer required for the study.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
12/LO/0494
Date of REC Opinion
25 Apr 2012
REC opinion
Favourable Opinion