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

Phase 3

Completed

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

Brief Summary: 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Experimental	Patient outreach	Experimental - treatment 300mg vandetanib opel label
Vandetanib Control	Vandetanib	Control - treatment 300mg vandetanib opel label
Experimental	Vandetanib	Experimental - treatment 300mg vandetanib opel label

Primary Outcome Measures

Name	Time	Method
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.	12 months	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.

Secondary Outcome Measures

Name	Time	Method

Locations (66): Investigational Site Number : 301
🇦🇺
St Leonards, New South Wales, Australia
Investigational Site Number : 401
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Wien, Austria
Investigational Site Number : 501
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Anderlecht, Belgium
Hospital De Clinicas De Porto Alegre Site Number : 701
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Porto Alegre, Rio Grande Do Sul, Brazil
Faculdade de Medicina de Ribeirao Preto - USP Site Number : 702
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Ribeirao Preto, São Paulo, Brazil
Investigational Site Number : 901
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Sofia, Bulgaria
Investigational Site Number : 1001
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London, Ontario, Canada
Investigational Site Number : 1003
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Toronto, Ontario, Canada
Investigational Site Number : 1002
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Sherbrooke, Quebec, Canada
Investigational Site Number : 1301
🇨🇳
Beijing, China
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Investigational Site Number : 301
🇦🇺St Leonards, New South Wales, Australia