ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
January 3, 2013 updated by: AstraZeneca
Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
This study is being carried out to see if ZD4054 (Zibotentan) 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 (Zibotentan).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
447
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nedlands, Australia
- Research Site
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Queensland
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Wolloongabba, Queensland, Australia
- Research Site
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South Australia
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Ashford, South Australia, Australia
- Research Site
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Victoria
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Wodonga, Victoria, Australia
- Research Site
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Brussels, Belgium
- Research Site
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Gent, Belgium
- Research Site
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Leuven, Belgium
- Research Site
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Quebec, Canada
- Research Site
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British Columbia
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Vancouver, British Columbia, Canada
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Ontario
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Arhus, Denmark
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Herlev, Denmark
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Helsinki, Finland
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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
- Research Site
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Fredrikstad, Norway
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Moelv, Norway
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Oslo, Norway
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Tonsberg, Norway
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Tromso, Norway
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Trondheim, Norway
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Bydgoszcz, Poland
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Katowice, Poland
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Warszawa, Poland
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Goteborg, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Geneve, 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
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Arizona
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Tucson, Arizona, United States
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California
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Los Angeles, California, United States
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Florida
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Gainsville, Florida, United States
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Illinois
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Chicago, Illinois, United States
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Maryland
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Baltimore, Maryland, United States
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Ohio
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Cleveland, Ohio, United States
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South Carolina
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Simpsonville, South Carolina, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Surgically or medically castrated
- Bone metastasis
- Rising PSA
Exclusion Criteria:
- Opiate use
- Prior chemotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Matching placebo oral tablet once daily, with best supportive care
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Experimental: ZD4054 10 mg
ZD4054 10 mg oral tablet once daily, with best supportive care
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10mg oral tablet once daily
Other Names:
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Experimental: ZD4054 15 mg
ZD4054 15 mg oral tablet once daily, with best supportive care
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15 mg oral tablet once daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Progression (TTP)
Time Frame: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).
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Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.
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Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Death
Time Frame: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).
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Median time (in days) from randomisation until death using the Kaplan-Meier method.
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Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).
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Change in Total Prostate Specific Antigen (PSA) Over Time
Time Frame: Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
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Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.
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Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
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Objective Response Rate (ORR)
Time Frame: For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
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Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST.
Objective Response Rate (ORR) is defined as the percentage of patients with OR.
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For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
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Change in Number of Bone Metastases Over Time
Time Frame: Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.
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Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.
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Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: AstraZeneca Emerging Oncology Medical Science Director, MD, AstraZeneca
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
August 25, 2004
First Submitted That Met QC Criteria
August 27, 2004
First Posted (Estimate)
August 30, 2004
Study Record Updates
Last Update Posted (Estimate)
January 8, 2013
Last Update Submitted That Met QC Criteria
January 3, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D4320C00006
- Trial 6
- ZD4054
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.