NCT01298323

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-02-25
• Primary completion: 2013-04-26
• Completion: 2025-03-13
• First posted: 2011-02-17
• Last updated: 2026-04-17
• Results posted: 2014-11-24

Locations

66 sites across 20 countries: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Finland, Germany, Greece, India, Israel, Italy, Poland, Russia, South Korea, Sweden, United Kingdom