Breast Cancer Clinical Trial
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease
Summary
The purpose of this study is to determine the effect of AZD0530 on subjects with breast cancer or prostate cancer with metastatic bone disease in comparison to zoledronic acid.
Eligibility Criteria
Inclusion Criteria:
Subjects 18 years or older with Prostate Cancer or Breast Cancer with Metastatic Bone Disease Have evidence of recurrence or disease progression
At least one radiographically confirmed metastatic bone lesion
No change of cancer therapy for at least 8 weeks before randomization
Exclusion Criteria:
Have had any prior exposure to bisphosphonate
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.
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There is 1 Location for this study
Pleasant Hill California, , United States
Sacramento California, , United States
Middlebury Connecticut, , United States
Aventura Florida, , United States
Baltimore Maryland, , United States
Ann Arbor Michigan, , United States
Poughkeepsie New York, , United States
Winston-salem North Carolina, , United States
Hershey Pennsylvania, , United States
Edmonton Alberta, , Canada
Vancouver British Columbia, , Canada
Toronto Ontario, , Canada
Montreal Quebec, , Canada
Quebec , , Canada
Arhus N , , Denmark
Frederica , , Denmark
Herlev , , Denmark
Holstebro , , Denmark
Kristiansand , , Norway
Oslo , , Norway
Lisboa , , Portugal
Barcelona Cataluna, , Spain
Lerida Cataluna, , Spain
Valencia Comunidad Valenciana, , Spain
Uppsala , , Sweden
Cardiff , , United Kingdom
Glasgow , , United Kingdom
Manchester , , United Kingdom
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