Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Thyroid Cancer, Medullary

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

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.

300mg 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.

150mg vandetanib

Clinical Sciences & Operations

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

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

ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1

Genzyme, a Sanofi Company

Vandetanib 150 mg

Vandetanib 300 mg

Total

Age, Continuous

>=18 to <40 years

>=40 to <65 years

>=65 to <75 years

>=75 years

Age, Customized

Sex: Female, Male

Asian

Black or African American

White

Other

Race/Ethnicity, Customized

Trial Transparency Team

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; ORR = CR + PR

Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator

Complete response

Partial response

Stable disease

Progressive disease

Non-evaluable

Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

Best Objective Response

Duration of Objective Response (RECIST 1.1) by Treatment Arm

Time to Objective Response (RECIST 1.1) by Treatment Arm

Week 12

Week 24

Week 36

Week 48

Follow-up RECIST assessment

Disc. of blinded vandetanib

Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm

Week 3 (Day 21)

Week 8 (Day 56)

Week 12 (Day 84)

Week 24 (Day 168)

Discontinuation of blinded vandetanib

All patients who received at least 1 dose of vandetanib and for whom quantifiable plasma concentration data were available.

Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.

Overall Study

Spots Global Cancer Trial Database for carcinoma of the thyroid