To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

PHASE4CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

June 8, 2012

Primary Completion Date

April 2, 2014

Study Completion Date

July 11, 2024

Conditions
Thyroid Cancer
Interventions
DRUG

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."

DRUG

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."

Trial Locations (30)

15006

Investigational Site Number : 1901, Prague

77900

Investigational Site Number : 1903, Olomouc

Unknown

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

02-781

Investigational Site Number : 5704, Warsaw

44-101

Investigational Site Number : 5703, Gliwice

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT01496313 - To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer | Biotech Hunter | Biotech Hunter