An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
NCT ID: NCT00410761
Last Updated: 2025-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
331 participants
INTERVENTIONAL
2006-11-23
2024-07-26
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
QUADRUPLE
Study Groups
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1
Placebo vandetanib
No interventions assigned to this group
2
Vandetanib
ZD6474 (Vandetanib)
once daily oral tablet
Interventions
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ZD6474 (Vandetanib)
once daily oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of measurable tumor
* Able to swallow medication
Exclusion Criteria
* Last dose of prior chemotherapy received less than 4 weeks prior to randomization
* Radiation therapy within the last 4 weeks prior to randomization(with exception of palliative radiotherapy)
* Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
* Significant cardiac events
* Previous ZD6474 treatment
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
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 3
Little Rock, Arkansas, United States
University Arkansas Site Number : 3
Little Rock, Arkansas, United States
Investigational Site Number 8
San Francisco, California, United States
USCF / Mt Zion Medical Center Site Number : 8
San Francisco, California, United States
Investigational Site Number 9
Aurora, Colorado, United States
University Of Colorado Health Sciences Center Site Number : 9
Aurora, Colorado, United States
Investigational Site Number 11
New Haven, Connecticut, United States
Yale University School Medicine Site Number : 11
New Haven, Connecticut, United States
Investigational Site Number 15
Jacksonville, Florida, United States
Mayo Clinic- Site Number : 15
Jacksonville, Florida, United States
Investigational Site Number 18
Chicago, Illinois, United States
The University Of Chicago Site Number : 18
Chicago, Illinois, United States
Investigational Site Number 17
Lexington, Kentucky, United States
The University Of Kentucky Site Number : 17
Lexington, Kentucky, United States
Dana Farber Cancer Institute Site Number : 2
Boston, Massachusetts, United States
Investigational Site Number 2
Boston, Massachusetts, United States
Investigational Site Number 7
Detroit, Michigan, United States
Wayne State University / Harper Hospital Site Number : 7
Detroit, Michigan, United States
Investigational Site Number 14
Rochester, Minnesota, United States
Mayo Clinic- Site Number : 14
Rochester, Minnesota, United States
Investigational Site Number 10
St Louis, Missouri, United States
Washington University School Of Med Site Number : 10
St Louis, Missouri, United States
Investigational Site Number 6
Cincinnati, Ohio, United States
University Of Cincinnati Site Number : 6
Cincinnati, Ohio, United States
Investigational Site Number 22
Portland, Oregon, United States
Oregon Health & Science University- Site Number : 22
Portland, Oregon, United States
Investigational Site Number 19
Charleston, South Carolina, United States
Medical University of South Carolina- Site Number : 19
Charleston, South Carolina, United States
Anderson Cancer Center Site Number : 13
Houston, Texas, United States
Investigational Site Number 13
Houston, Texas, United States
Fletcher Allen Health Care Site Number : 21
Burlington, Vermont, United States
Investigational Site Number 21
Burlington, Vermont, United States
Investigational Site Number 1001
St Leonards, , Australia
Investigational Site Number 1901
Vienna, , Austria
Investigational Site Number : 1901
Vienna, , Austria
Investigational Site Number : 1101
Anderlecht, , Belgium
Investigational Site Number 1101
Brussels, , Belgium
Investigational Site Number 1102
Leuven, , Belgium
Investigational Site Number : 1102
Leuven, , Belgium
Hospital De Clinicas De Porto Alegre- Site Number : 2301
Porto Alegre, Rio Grande do Sul, Brazil
Faculdade de Medicina de Ribeirao Preto - USP- Site Number : 2302
Ribeirão Preto, São Paulo, Brazil
Investigational Site Number 2301
Porto Alegre, , Brazil
Investigational Site Number 2302
Ribeirão Preto, , Brazil
Investigational Site Number : 1203
Calgary, Alberta, Canada
Investigational Site Number : 1201
Moncton, New Brunswick, Canada
Investigational Site Number : 1202
London, Ontario, Canada
Investigational Site Number : 1205
Toronto, Ontario, Canada
Investigational Site Number : 1204
Sherbrooke, Quebec, Canada
Investigational Site Number 1203
Calgary, , Canada
Investigational Site Number 1202
London, , Canada
Investigational Site Number 1201
Moncton, , Canada
Investigational Site Number 1204
Sherbrooke, , Canada
Investigational Site Number 1205
Toronto, , Canada
Investigational Site Number 3601
Prague, , Czechia
Investigational Site Number : 3601
Prague, , Czechia
Investigational Site Number 2701
Odense C, , Denmark
Investigational Site Number : 2701
Odense C, , Denmark
Investigational Site Number 2802
Bordeaux, , France
Investigational Site Number : 2802
Bordeaux, , France
Investigational Site Number 2803
Lyon, , France
Investigational Site Number : 2803
Lyon, , France
Investigational Site Number 2801
Villejuif, , France
Investigational Site Number : 2801
Villejuif, , France
Investigational Site Number 2002
Essen, , Germany
Investigational Site Number : 2002
Essen, , Germany
Investigational Site Number 2001
Halle, , Germany
Investigational Site Number : 2001
Halle, , Germany
Investigational Site Number 2005
Würzburg, , Germany
Investigational Site Number : 2005
Würzburg, , Germany
Investigational Site Number 1601
Pécs, , Hungary
Investigational Site Number : 1601
Pécs, , Hungary
Investigational Site Number 1401
Mumbai, , India
Investigational Site Number : 1401
Mumbai, , India
Investigational Site Number 1402
Vellore, , India
Investigational Site Number : 1402
Vellore, , India
Investigational Site Number 2506
Catania, , Italy
Investigational Site Number : 2506
Catania, , Italy
Investigational Site Number 2502
Milan, , Italy
Investigational Site Number : 2502
Milan, , Italy
Investigational Site Number 2503
Napoli, , Italy
Investigational Site Number : 2503
Napoli, , Italy
Investigational Site Number 2501
Pisa, , Italy
Investigational Site Number : 2501
Pisa, , Italy
Investigational Site Number 2505
Roma, , Italy
Investigational Site Number : 2505
Roma, , Italy
Investigational Site Number 2504
Siena, , Italy
Investigational Site Number : 2504
Siena, , Italy
Investigational Site Number 2403
Ciudad Madero, , Mexico
Investigational Site Number 2402
Mexico City, , Mexico
Investigational Site Number 2404
México, , Mexico
Investigational Site Number : 2404
México, , Mexico
Investigational Site Number 2902
Groningen, , Netherlands
Investigational Site Number : 2902
Groningen, , Netherlands
Investigational Site Number 2901
Utrecht, , Netherlands
Investigational Site Number : 2901
Utrecht, , Netherlands
Investigational Site Number : 1702
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 1703
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number 1701
Gliwice, , Poland
Investigational Site Number : 1701
Gliwice, , Poland
Investigational Site Number 1702
Poznan, , Poland
Investigational Site Number 1703
Warsaw, , Poland
Investigational Site Number 2602
Coimbra, , Portugal
Investigational Site Number 2601
Lisbon, , Portugal
Investigational Site Number : 2601
Lisbon, , Portugal
Investigational Site Number 1801
Bucharest, , Romania
Investigational Site Number 3301
Obninsk, , Russia
Investigational Site Number : 3301
Obninsk, , Russia
Investigational Site Number 3401
Belgrade, , Serbia
Investigational Site Number : 3401
Belgrade, , Serbia
Investigational Site Number 3402
Belgrade, , Serbia
Investigational Site Number : 3402
Belgrade, , Serbia
Investigational Site Number : 1501
Seoul, , South Korea
Investigational Site Number 1501
Seoul, , South Korea
Investigational Site Number : 3002
Pamplona, Navarre, Spain
Investigational Site Number 3003
Madrid, , Spain
Investigational Site Number : 3003
Madrid, , Spain
Investigational Site Number 3001
Madrid, , Spain
Investigational Site Number : 3001
Madrid, , Spain
Investigational Site Number 3002
Pamplona, , Spain
Investigational Site Number 3102
Stockholm, , Sweden
Investigational Site Number : 3102
Stockholm, , Sweden
Investigational Site Number 3101
Uppsala, , Sweden
Investigational Site Number : 3101
Uppsala, , Sweden
Investigational Site Number 2101
Basel, , Switzerland
Investigational Site Number : 2101
Basel, , Switzerland
Investigational Site Number 2102
Bern, , Switzerland
Investigational Site Number : 2102
Bern, , Switzerland
Countries
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References
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Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. doi: 10.1200/JCO.2011.35.5040. Epub 2011 Oct 24.
Related Links
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Other Identifiers
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LPS14811
Identifier Type: OTHER
Identifier Source: secondary_id
2005-005077-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4200C00058
Identifier Type: -
Identifier Source: org_study_id
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