Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease

Completed · Phase 2

Conditions studied: Breast Cancer, Prostate Cancer, Bone Neoplasms

In brief

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.

Key facts

Study ID

NCT00558272

Run by

AstraZeneca

People needed

139

Starts

2008-02-01

Expected to finish

2012-08-01

Last updated by the study team

2013-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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