Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease
NCT ID: NCT00558272
Last Updated: 2013-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
139 participants
INTERVENTIONAL
2008-02-29
2012-08-31
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
NONE
Study Groups
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AZD0530 175 mg
AZD0530 (saracatinib) 175 mg once daily
AZD0530
Daily oral dose
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
Zoledronic Acid
Interventions
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AZD0530
Daily oral dose
Zoledronic Acid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one radiographically confirmed metastatic bone lesion
* No change of cancer therapy for at least 8 weeks before randomization
Exclusion Criteria
* Have had hip fractures or bilateral hip prothesis fracture of any kind or surgery to bone within the past 12 months
* Inadequate renal function or low haemoglobin
* Inadequate liver function as demonstrated by serum bilirubin ≥2 times the upper limits of reference range (ULRR) or by alanine aminotransferase (ALT), aspartate aminotransferase(AST) or ALP ≥2.5 times the ULRR (≥5 times the ULRR in the presence of liver metastases). If bone metastases are present and liver function is otherwise considered adequate by the investigator then elevated ALP will not exclude the patient.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Finkelman, DDS, PhD
Role: STUDY_DIRECTOR
AstraZeneca
Meabe Aklilu, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Research Site
Pleasant Hill, California, United States
Research Site
Sacramento, California, United States
Research Site
Middlebury, Connecticut, United States
Research Site
Aventura, Florida, United States
Research Site
Baltimore, Maryland, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Poughkeepsie, New York, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Arhus N, , Denmark
Research Site
Frederica, , Denmark
Research Site
Herlev, , Denmark
Research Site
Holstebro, , Denmark
Research Site
Kristiansand, , Norway
Research Site
Oslo, , Norway
Research Site
Lisbon, , Portugal
Research Site
Barcelona, Catalonia, Spain
Research Site
Lleida, Catalonia, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Uppsala, , Sweden
Research Site
Cardiff, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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Other Identifiers
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D8180C00034
Identifier Type: -
Identifier Source: org_study_id
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