Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
NCT ID: NCT00364351
Last Updated: 2018-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1574 participants
INTERVENTIONAL
2006-08-31
2016-11-30
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
Erlotinib
Erlotinib
oral dose
2
Vandetanib
Vandetanib
once daily oral tablet
Interventions
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Vandetanib
once daily oral tablet
Erlotinib
oral dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failure of at least one but not more than two prior chemotherapy regimens
Exclusion Criteria
* Chemotherapy or other type of anti cancer therapy within 4 weeks of study start
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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Research Site
Berkeley, California, United States
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Los Angeles, California, United States
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Santa Rosa, California, United States
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Boynton Beach, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Port Saint Lucie, Florida, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Latham, New York, United States
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Hickory, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Garland, Texas, United States
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Webster, Texas, United States
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Fairfax, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Burien, Washington, United States
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Yakima, Washington, United States
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Manuel B. Gonnet, , Argentina
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Ramos Mejía, , Argentina
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Rosario, , Argentina
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Santa Fe, , Argentina
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Ashford, , Australia
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Bedford Park, , Australia
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Chermside, , Australia
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Geelong, , Australia
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Hornsby, , Australia
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Kogarah, , Australia
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Malvern, , Australia
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Prahran, , Australia
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Wodonga, , Australia
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Belo Horizonte, , Brazil
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Caxias do Sul, , Brazil
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Curitiba, , Brazil
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Goiânia, , Brazil
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Porto Alegre, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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York, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Dalian, , China
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Hangzhou, , China
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Nanjing, , China
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Nanning, , China
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Shanghai, , China
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Shenyang, , China
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Wuhan, , China
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Herlev, , Denmark
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København Ø, , Denmark
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Næstved, , Denmark
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Caen, , France
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Clermont-Ferrand, , France
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Marseille, , France
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Paris, , France
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Rennes, , France
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Vesoul, , France
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Göttingen, , Germany
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Großhansdorf, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Karlsruhe, , Germany
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Löwenstein, , Germany
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Mainz, , Germany
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Mönchengladbach, , Germany
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Ulm, , Germany
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Hong Kong, , Hong Kong
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Bangalore, , India
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Karnataka, , India
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New Delhi, , India
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Pune, , India
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Trivandrum, , India
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Bandung, , Indonesia
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Jakarta, , Indonesia
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Solo, , Indonesia
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Ancona, , Italy
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Avellino, , Italy
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Catania, , Italy
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Genova, , Italy
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Mantova, , Italy
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Milan, , Italy
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Orbassano, , Italy
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Parma, , Italy
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Perugia, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Juchitán, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Puebla City, , Mexico
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Saltillo, , Mexico
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Zacatecas City, , Mexico
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Harderwijk, , Netherlands
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Nieuwegein, , Netherlands
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Rotterdam, , Netherlands
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Zwolle, , Netherlands
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Bergen, , Norway
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Haugesund, , Norway
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Kristiansand, , Norway
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Oslo, , Norway
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Stavanger, , Norway
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Tromsø, , Norway
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Trondheim, , Norway
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Cebu City, , Philippines
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Davao City, , Philippines
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Manila, , Philippines
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Pasay, , Philippines
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Quezon City, , Philippines
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Seoul, , South Korea
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Elche(Alicante), , Spain
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Jaén, , Spain
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Madrid, , Spain
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Mataró(Barcelona), , Spain
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Málaga, , Spain
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Pamplona, , Spain
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Lampang, , Thailand
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Songkhla, , Thailand
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Birmingham, , United Kingdom
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Cambridge, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, Ferry D, Mulatero C, Whorf R, Thompson J, Barlesi F, Langmuir P, Gogov S, Rowbottom JA, Goss GD. Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1059-66. doi: 10.1200/JCO.2010.28.5981. Epub 2011 Jan 31.
Mishina A, Zhudenkov K, Helmlinger G, Peskov K. A Systematic Comparative Analysis of Tumor Size Models Based on Erlotinib Clinical Data in Advanced NSCLC. CPT Pharmacometrics Syst Pharmacol. 2025 Aug 11. doi: 10.1002/psp4.70095. Online ahead of print.
Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.
Related Links
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Vandetanib\_study\_57\_ZEST\_CSP\_redacted\_SECURE
Other Identifiers
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EUDRACT No. 2006-000259-16
Identifier Type: -
Identifier Source: secondary_id
D4200C00057
Identifier Type: -
Identifier Source: org_study_id
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