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 (88)

• Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 2 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 2 ] [ Designated as safety issue: Yes ]
  Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
• Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program (week 0) [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 0 ] [ Designated as safety issue: Yes ]
  Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
• Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 4 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 4 ] [ Designated as safety issue: Yes ]
  Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
• Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 8 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 8 ] [ Designated as safety issue: Yes ]
  Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
• Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 13 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 13 ] [ Designated as safety issue: Yes ]
  Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
• Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 26 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 26 ] [ Designated as safety issue: Yes ]
  Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
• Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 39 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 39 ] [ Designated as safety issue: Yes ]
  Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
• Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 52 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 52 ] [ Designated as safety issue: Yes ]
  Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program

• Frequency and severity of adverse events. [ Time Frame: Over the 52 weeks on study treatment and 60 day follow up ] [ Designated as safety issue: Yes ]
• Vital signs including pulse rate and blood pressure. [ Time Frame: Over the 52 weeks on study treatment ] [ Designated as safety issue: Yes ]
• Clinically significant laboratory abnormalities. [ Time Frame: Over the 52 weeks on study treatment ] [ Designated as safety issue: Yes ]
• ECG abnormalities ECG abnormalities. [ Time Frame: Over the 52 weeks on study treatment ] [ Designated as safety issue: Yes ]

• To collect additional information on the safety and tolerability (week 0) [ Time Frame: Over 52 weeks on treatment (week 0) ] [ Designated as safety issue: Yes ]
  To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
• To collect additional information on the safety and tolerability (week 2) [ Time Frame: Over 52 weeks on treatment (week 2) ] [ Designated as safety issue: Yes ]
  To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
• To collect additional information on the safety and tolerability (week 4) [ Time Frame: Over 52 weeks on treatment (week 4) ] [ Designated as safety issue: Yes ]
  To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
• To collect additional information on the safety and tolerability (week 8) [ Time Frame: Over 52 weeks on treatment (week 8) ] [ Designated as safety issue: Yes ]
  To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
• To collect additional information on the safety and tolerability (week 13) [ Time Frame: Over 52 weeks on treatment (week 13) ] [ Designated as safety issue: Yes ]
  To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
• To collect additional information on the safety and tolerability (week 26) [ Time Frame: Over 52 weeks on treatment (week 26) ] [ Designated as safety issue: Yes ]
  To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
• To collect additional information on the safety and tolerability (week 39) [ Time Frame: Over 52 weeks on treatment (week 39) ] [ Designated as safety issue: Yes ]
  To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
• To collect additional information on the safety and tolerability (week 52) [ Time Frame: Over 52 weeks on treatment (week 52) ] [ Designated as safety issue: Yes ]
  To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities

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

• Locally Advanced or Metastatic Medullary Thyroid Cancer
• Medullary Thyroid Cancer

• Behavioral: Patient outreach
  Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner
• Drug: Vandetanib
  Treatment 300mg vandetanib opel label.

• Active Comparator: Vandetanib Control
  Control - treatment 300mg vandetanib opel label
  Intervention: Drug: Vandetanib
• Experimental: Experimental
  Experimental - treatment 300mg vandetanib opel label
  Interventions:

  • Behavioral: Patient outreach
  • Drug: Vandetanib

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