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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
81
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.
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.
Research Site
Houston, Texas, United States
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
Time frame: Randomisation to week 60 (maximum)
Best Objective Response
Time frame: Randomisation to week 60 (maximum)
Duration of Objective Response (RECIST 1.1) by Treatment Arm
Time frame: Randomization to Week 60 (maximum)
Time to Objective Response (RECIST 1.1) by Treatment Arm
Time frame: Randomization to Week 60 (maximum)
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Time frame: Randomization to Week 60 (maximum)
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Time frame: Week 3 to week 60 (maximum)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site Number : 1903
Olomouc, Czechia
Research Site
Olomouc, Czechia
Investigational Site Number : 1901
Prague, Czechia
Research Site
Prague, Czechia
Research Site
Bangalore Karnataka, India
Research Site
Vellore, India
Research Site
Beersheba, Israel
Research Site
Haifa, Israel
Research Site
Jerusalem, Israel
...and 20 more locations