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
NCT ID: NCT01298323
Last Updated: 2025-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
205 participants
INTERVENTIONAL
2011-02-25
2025-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vandetanib Control
Control - treatment 300mg vandetanib opel label
Vandetanib
Treatment 300mg vandetanib opel label.
Experimental
Experimental - treatment 300mg vandetanib opel label
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Napoli, , Italy
Investigational Site Number : 4104
Napoli, , 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
Countries
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Related Links
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Other Identifiers
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LPS14815
Identifier Type: OTHER
Identifier Source: secondary_id
2010-023428-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4200C00088
Identifier Type: -
Identifier Source: org_study_id
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