ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
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)
3 other identifiers
interventional
447
14 countries
60
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Jul 2004
Longer than P75 for phase_2 prostate-cancer
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 25, 2004
CompletedFirst Posted
Study publicly available on registry
August 30, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
September 3, 2012
CompletedJanuary 8, 2013
January 1, 2013
4.4 years
August 25, 2004
April 26, 2012
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Progression (TTP)
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.
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).
Secondary Outcomes (4)
Time to Death
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).
Change in Total Prostate Specific Antigen (PSA) Over Time
Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
Objective Response Rate (ORR)
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).
Change in Number of Bone Metastases Over Time
Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.
Study Arms (3)
Placebo
PLACEBO COMPARATORMatching placebo oral tablet once daily, with best supportive care
ZD4054 10 mg
EXPERIMENTALZD4054 10 mg oral tablet once daily, with best supportive care
ZD4054 15 mg
EXPERIMENTALZD4054 15 mg oral tablet once daily, with best supportive care
Interventions
Eligibility Criteria
You may qualify if:
- Surgically or medically castrated
- Bone metastasis
- Rising PSA
You may not qualify if:
- Opiate use
- Prior chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (60)
Research Site
Tucson, Arizona, United States
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Los Angeles, California, United States
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Gainsville, Florida, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Cleveland, Ohio, United States
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Simpsonville, South Carolina, United States
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Wolloongabba, Queensland, Australia
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Ashford, South Australia, Australia
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Wodonga, Victoria, Australia
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Nedlands, Australia
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Aarhus, 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
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Fredrikstad, Norway
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Moelv, Norway
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Oslo, Norway
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Tromsø, Norway
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Trondheim, Norway
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Tønsberg, Norway
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Bydgoszcz, Poland
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Katowice, Poland
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Warsaw, Poland
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Gothenburg, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Geneva, 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
Related Publications (1)
James ND, Caty A, Borre M, Zonnenberg BA, Beuzeboc P, Morris T, Phung D, Dawson NA. Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: a double-blind, placebo-controlled, randomised, phase 2 trial. Eur Urol. 2009 May;55(5):1112-23. doi: 10.1016/j.eururo.2008.11.002. Epub 2008 Nov 29.
PMID: 19042080DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
'Final analysis' results (data cut-off 18th December 2008) should be considered in context with the longevity of the follow-up (median duration approximately 22 months) relative to only approximately 4 months median duration of study treatment.
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca Emerging Oncology Medical Science Director, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2004
First Posted
August 30, 2004
Study Start
July 1, 2004
Primary Completion
December 1, 2008
Study Completion
August 1, 2011
Last Updated
January 8, 2013
Results First Posted
September 3, 2012
Record last verified: 2013-01