Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib

Official Title
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A Randomized,Int.,Open-Label Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients With Locally Advanced or Metastatic MTC Experience Grade 2 or Higher AEs in the First 12 Months of Treatment With Vandetanib

Conditions
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Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer

Intervention / Treatment
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* Behavioral: Patient outreach
* Drug: Vandetanib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures Female or male aged 18 years and over Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient's medical chart WHO or ECOG Performance status 0-2 Negative pregnancy test (urine or serum) for female patients of childbearing potential Exclusion Criteria: Unstable brain metastases or spinal cord compression that require treatment, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days Major surgery within 4 weeks before randomization The last dose of prior chemotherapy received less than 3 weeks prior to randomization Radiation therapy not completed prior to the first dose of vandetanib Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhythmia Creatinine clearance <30 ml/min (calculated by Cockcroft-Gault formula),Patients with moderate renal impairment, defined as creatinine clearance ≥30 to <50 ml/min, must start vandetanib at a reduced dose of 200 mg

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vandetanib Control<br>Control - treatment 300mg vandetanib opel label | Drug: Vandetanib<br>* Treatment 300mg vandetanib opel label.<br>* Other names: SAR390530;|
| Experimental: Experimental<br>Experimental - treatment 300mg vandetanib opel label | Behavioral: Patient outreach<br>* Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner<br>Drug: Vandetanib<br>* Treatment 300mg vandetanib opel label.<br>* Other names: SAR390530;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program. | The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medullary Thyroid Cancer, Locally advanced, Metastatic, Vandetanib, Patient Outreach