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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00090363
Registration number
NCT00090363
Ethics application status
Date submitted
25/08/2004
Date registered
30/08/2004
Date last updated
8/01/2013
Titles & IDs
Public title
ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
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Scientific title
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)
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Secondary ID [1]
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Trial 6
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Secondary ID [2]
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D4320C00006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ZD4054 15 mg
Treatment: Drugs - ZD4054 10 mg
Placebo comparator: Placebo - Matching placebo oral tablet once daily, with best supportive care
Experimental: ZD4054 10 mg - ZD4054 10 mg oral tablet once daily, with best supportive care
Experimental: ZD4054 15 mg - ZD4054 15 mg oral tablet once daily, with best supportive care
Treatment: Drugs: ZD4054 15 mg
15 mg oral tablet once daily
Treatment: Drugs: ZD4054 10 mg
10mg oral tablet once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Progression (TTP)
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Assessment method [1]
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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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Timepoint [1]
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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 [1]
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Time to Death
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Assessment method [1]
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Median time (in days) from randomisation until death using the Kaplan-Meier method.
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Timepoint [1]
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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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Secondary outcome [2]
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Change in Total Prostate Specific Antigen (PSA) Over Time
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Assessment method [2]
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Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.
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Timepoint [2]
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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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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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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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Timepoint [3]
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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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Secondary outcome [4]
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Change in Number of Bone Metastases Over Time
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Assessment method [4]
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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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Timepoint [4]
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Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.
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Eligibility
Key inclusion criteria
* Surgically or medically castrated
* Bone metastasis
* Rising PSA
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Opiate use
* Prior chemotherapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
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Accrual to date
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Final
447
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Research Site - Wolloongabba
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Recruitment hospital [2]
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Research Site - Ashford
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Recruitment hospital [3]
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Research Site - Wodonga
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Recruitment hospital [4]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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- Wolloongabba
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Recruitment postcode(s) [2]
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- Ashford
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Recruitment postcode(s) [3]
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- Wodonga
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Recruitment postcode(s) [4]
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- Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Gent
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Canada
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Ontario
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Herlev
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Joensuu
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Finland
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OYS
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Lille
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Paris
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France
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Pontoise
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France
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Bydgoszcz
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Birmingham
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York
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT00090363
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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AstraZeneca Emerging Oncology Medical Science Director, MD
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Address
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AstraZeneca
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00090363
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