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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00090363 |
This study is being carried out to see if ZD4054 is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: ZD4054 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Centre Study to Assess ZD4054 in Pain-Free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA) |
Estimated Enrollment: | 260 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
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1: No Intervention
Placebo ZD4054
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2: Experimental
ZD4054
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Drug: ZD4054
Oral Tablet 10mg or 15 mg
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Emerging Oncology Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D4320C00006, Trial 6, ZD4054 |
Study First Received: | August 25, 2004 |
Last Updated: | December 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00090363 |
Health Authority: | United States: Food and Drug Administration |
rising PSA bone metastases Clinical study pain-free or mildly symptomatic |
Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis Urogenital Neoplasms |
Pain Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |