ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
NCT ID: NCT00090363
Last Updated: 2013-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
447 participants
INTERVENTIONAL
2004-07-31
2011-08-31
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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Placebo
Matching placebo oral tablet once daily, with best supportive care
Placebo
ZD4054 10 mg
ZD4054 10 mg oral tablet once daily, with best supportive care
ZD4054 10 mg
10mg oral tablet once daily
ZD4054 15 mg
ZD4054 15 mg oral tablet once daily, with best supportive care
ZD4054 15 mg
15 mg oral tablet once daily
Interventions
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ZD4054 15 mg
15 mg oral tablet once daily
Placebo
ZD4054 10 mg
10mg oral tablet once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bone metastasis
* Rising PSA
Exclusion Criteria
* Prior chemotherapy
18 Years
MALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Emerging Oncology Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Tucson, Arizona, United States
Research Site
Los Angeles, California, United States
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Gainsville, Florida, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Cleveland, Ohio, United States
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Simpsonville, South Carolina, United States
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Wolloongabba, Queensland, Australia
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Ashford, South Australia, Australia
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Wodonga, Victoria, Australia
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Nedlands, , Australia
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
Research site
Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Aarhus, , Denmark
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Herlev, , Denmark
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Helsinki, , Finland
Research Site
Joensuu, , Finland
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OYS, , Finland
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Seinäjoki, , Finland
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Tampere, , Finland
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Lille, , France
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Montpellier, , France
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Paris, , France
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Pontoise, , France
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Toulouse, , France
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Jakarta, , Indonesia
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Eindhoven, , Netherlands
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Groningen, , Netherlands
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Heerlen, , Netherlands
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Leiden, , Netherlands
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Rotterdam, , Netherlands
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Utrecht, , Netherlands
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Bergen, , Norway
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Fredrikstad, , Norway
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Moelv, , Norway
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Oslo, , Norway
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Tromsø, , Norway
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Trondheim, , Norway
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Tønsberg, , Norway
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Bydgoszcz, , Poland
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Katowice, , Poland
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Warsaw, , Poland
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Gothenburg, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Geneva, , Switzerland
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Locarno, , Switzerland
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Birmingham, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Maidstone, , United Kingdom
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Manchester, , United Kingdom
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Newcastle, , United Kingdom
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York, , United Kingdom
Countries
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References
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James ND, Caty A, Borre M, Zonnenberg BA, Beuzeboc P, Morris T, Phung D, Dawson NA. Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: a double-blind, placebo-controlled, randomised, phase 2 trial. Eur Urol. 2009 May;55(5):1112-23. doi: 10.1016/j.eururo.2008.11.002. Epub 2008 Nov 29.
Other Identifiers
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Trial 6
Identifier Type: -
Identifier Source: secondary_id
ZD4054
Identifier Type: -
Identifier Source: secondary_id
D4320C00006
Identifier Type: -
Identifier Source: org_study_id
NCT00107146
Identifier Type: -
Identifier Source: nct_alias
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