Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
NCT ID: NCT00777153
Last Updated: 2016-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
423 participants
INTERVENTIONAL
2008-10-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cediranib 30mg
Cediranib 30mg
Cediranib
30 mg/day, oral, until progression
Cediranib 20mg + lomustine
Cediranib 20mg + lomustine
Cediranib
20 mg/day, oral, until progression
Lomustine Chemotherapy
110 mg/m2 / Q6W, oral, until progression
Lomustine and Placebo Cediranib
Lomustine and Placebo Cediranib
Lomustine Chemotherapy
110 mg/m2 / Q6W, oral, until progression
Placebo Cediranib
Oral, until progression
Interventions
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Cediranib
30 mg/day, oral, until progression
Cediranib
20 mg/day, oral, until progression
Lomustine Chemotherapy
110 mg/m2 / Q6W, oral, until progression
Placebo Cediranib
Oral, until progression
Eligibility Criteria
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Inclusion Criteria
* Life expectancy ≥ 12 weeks
* Received only one prior systemic chemotherapy regimen and this regimen must contain temozolomide
Exclusion Criteria
* Poorly controlled hypertension
* Previous anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) therapy
18 Years
100 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Jane Robertson
Role: STUDY_DIRECTOR
AstraZeneca
Tracy Batchelor, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Pheonix, Arizona, United States
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Los Angeles, California, United States
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New Haven, Connecticut, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Kansas City, Kansas, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Amherst, New York, United States
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New York, New York, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Camperdown, , Australia
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Heidelberg, , Australia
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Nedlands, , Australia
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Parkville, , Australia
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St Leonards, , Australia
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Woodville, , Australia
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Graz, , Austria
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Brussels (Anderlecht), , Belgium
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Brussels (Jette), , Belgium
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Brussels (Woluwé-St-Lambert), , Belgium
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Leuven, , Belgium
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Calgary, Alberta, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Liberec, , Czechia
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Bobigny, , France
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Marseille, , France
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Paris, , France
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Rennes, , France
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Saint-Herblain, , France
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Villejuif, , France
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Berlin, , Germany
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Bielefeld, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Göttingen, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Nordhausen, , Germany
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Regensburg, , Germany
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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The Hague, , Netherlands
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Glasgow, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Sutton, , United Kingdom
Countries
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References
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Batchelor TT, Mulholland P, Neyns B, Nabors LB, Campone M, Wick A, Mason W, Mikkelsen T, Phuphanich S, Ashby LS, Degroot J, Gattamaneni R, Cher L, Rosenthal M, Payer F, Jurgensmeier JM, Jain RK, Sorensen AG, Xu J, Liu Q, van den Bent M. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol. 2013 Sep 10;31(26):3212-8. doi: 10.1200/JCO.2012.47.2464. Epub 2013 Aug 12.
Related Links
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Other Identifiers
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D8480C00055
Identifier Type: -
Identifier Source: org_study_id