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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
Sponsor: Sanofi
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
205
Start Date
2011-02-25
Completion Date
2025-03-13
Last Updated
2026-04-17
Healthy Volunteers
No
Interventions
Patient outreach
Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner
Vandetanib
Treatment 300mg vandetanib opel label.
Locations (66)
Investigational Site Number : 301
St Leonards, New South Wales, Australia
Investigational Site Number 301
St Leonards, Australia
Investigational Site Number 401
Vienna, Austria
Investigational Site Number : 401
Vienna, Austria
Investigational Site Number : 501
Anderlecht, Belgium
Investigational Site Number 501
Brussels, Belgium
Hospital De Clinicas De Porto Alegre Site Number : 701
Porto Alegre, Rio Grande do Sul, Brazil
Faculdade de Medicina de Ribeirao Preto - USP Site Number : 702
Ribeirão Preto, São Paulo, Brazil
Investigational Site Number 701
Porto Alegre, Brazil
Investigational Site Number 702
Ribeirão Preto, Brazil
Investigational Site Number 901
Sofia, Bulgaria
Investigational Site Number : 901
Sofia, Bulgaria
Investigational Site Number : 1001
London, Ontario, Canada
Investigational Site Number : 1003
Toronto, Ontario, Canada
Investigational Site Number : 1002
Sherbrooke, Quebec, Canada
Investigational Site Number 1001
London, Canada
Investigational Site Number 1002
Sherbrooke, Canada
Investigational Site Number 1003
Toronto, Canada
Investigational Site Number 1301
Beijing, China
Investigational Site Number : 1301
Beijing, China
Investigational Site Number 1302
Shanghai, China
Investigational Site Number : 1302
Shanghai, China
Investigational Site Number 1901
Prague, Czechia
Investigational Site Number : 1901
Prague, Czechia
Investigational Site Number 2001
Odense C, Denmark
Investigational Site Number : 2001
Odense C, Denmark
Investigational Site Number 2201
Helsinki, Finland
Investigational Site Number : 2201
Helsinki, Finland
Investigational Site Number 2602
Essen, Germany
Investigational Site Number : 2602
Essen, Germany
Investigational Site Number 2603
Halle, Germany
Investigational Site Number : 2603
Halle, Germany
Investigational Site Number 2601
Würzburg, Germany
Investigational Site Number : 2601
Würzburg, Germany
Investigational Site Number 3001
Athens, Greece
Investigational Site Number : 3001
Athens, Greece
Investigational Site Number 3501
Mumbai, India
Investigational Site Number : 3501
Mumbai, India
Investigational Site Number 3502
Vellore, India
Investigational Site Number : 3502
Vellore, India
Investigational Site Number 4001
Jerusalem, Israel
Investigational Site Number : 4001
Jerusalem, Israel
Investigational Site Number 4104
Naples, Italy
Investigational Site Number : 4104
Naples, Italy
Investigational Site Number 4101
Pisa, Italy
Investigational Site Number : 4101
Pisa, Italy
Investigational Site Number 4102
Roma, Italy
Investigational Site Number : 4102
Roma, Italy
Investigational Site Number : 5702
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 5703
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number 5702
Poznan, Poland
Investigational Site Number 5703
Warsaw, Poland
Investigational Site Number 6201
Moscow, Russia
Investigational Site Number : 6201
Moscow, Russia
Investigational Site Number 6204
Moscow, Russia
Investigational Site Number 6202
Obninsk, Russia
Investigational Site Number : 6202
Obninsk, Russia
Investigational Site Number 6203
Saint Petersburg, Russia
Investigational Site Number : 6001
Seoul, South Korea
Investigational Site Number 6001
Seoul, South Korea
Investigational Site Number 7201
Uppsala, Sweden
Investigational Site Number : 7201
Uppsala, Sweden
Investigational Site Number : 2801
Sutton, Surrey, United Kingdom
Investigational Site Number 2802
Glasgow, United Kingdom
Investigational Site Number : 2802
Glasgow, United Kingdom
Investigational Site Number 2801
Sutton, United Kingdom