81
Participants
Start Date
June 8, 2012
Primary Completion Date
April 2, 2014
Study Completion Date
July 11, 2024
300mg vandetanib
"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."
150mg vandetanib
"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."
Investigational Site Number : 1901, Prague
Investigational Site Number : 1903, Olomouc
Research Site, Houston
Research Site, Olomouc
Research Site, Prague
Research Site, Bangalore Karnataka
Research Site, Vellore
Research Site, Beersheba
Research Site, Haifa
Research Site, Jerusalem
Research Site, Petah Tikva
Research Site, Catania
Research Site, Milan
Research Site, Palermo
Research Site, Pisa
Research Site, Roma
Research Site, Siena
Research Site, Torino
Research Site, Groningen
Research Site, Leiden
Research Site, Gliwice
Research Site, Warsaw
Research Site, Zgierz
Research Site, Saint Petersburg
Research Site, Cardiff
Research Site, Greater London
Research Site, London
Research Site, Tyne & Wear
Investigational Site Number : 5704, Warsaw
Investigational Site Number : 5703, Gliwice
Lead Sponsor
Sanofi
INDUSTRY