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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)
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)
Secondary ID [1] 0 0
Trial 6
Secondary ID [2] 0 0
D4320C00006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Progression (TTP)
Timepoint [1] 0 0
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 outcome [1] 0 0
Time to Death
Timepoint [1] 0 0
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).
Secondary outcome [2] 0 0
Change in Total Prostate Specific Antigen (PSA) Over Time
Timepoint [2] 0 0
Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
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).
Secondary outcome [4] 0 0
Change in Number of Bone Metastases Over Time
Timepoint [4] 0 0
Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.

Eligibility
Key inclusion criteria
* Surgically or medically castrated
* Bone metastasis
* Rising PSA
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Opiate use
* Prior chemotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
447
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Wolloongabba
Recruitment hospital [2] 0 0
Research Site - Ashford
Recruitment hospital [3] 0 0
Research Site - Wodonga
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Wolloongabba
Recruitment postcode(s) [2] 0 0
- Ashford
Recruitment postcode(s) [3] 0 0
- Wodonga
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussels
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Denmark
State/province [14] 0 0
Arhus
Country [15] 0 0
Denmark
State/province [15] 0 0
Herlev
Country [16] 0 0
Finland
State/province [16] 0 0
Helsinki
Country [17] 0 0
Finland
State/province [17] 0 0
Joensuu
Country [18] 0 0
Finland
State/province [18] 0 0
OYS
Country [19] 0 0
Finland
State/province [19] 0 0
Seinäjoki
Country [20] 0 0
Finland
State/province [20] 0 0
Tampere
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Montpellier
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Pontoise
Country [25] 0 0
France
State/province [25] 0 0
Toulouse
Country [26] 0 0
Indonesia
State/province [26] 0 0
Jakarta
Country [27] 0 0
Netherlands
State/province [27] 0 0
Eindhoven
Country [28] 0 0
Netherlands
State/province [28] 0 0
Groningen
Country [29] 0 0
Netherlands
State/province [29] 0 0
Heerlen
Country [30] 0 0
Netherlands
State/province [30] 0 0
Leiden
Country [31] 0 0
Netherlands
State/province [31] 0 0
Rotterdam
Country [32] 0 0
Netherlands
State/province [32] 0 0
Utrecht
Country [33] 0 0
Norway
State/province [33] 0 0
Bergen
Country [34] 0 0
Norway
State/province [34] 0 0
Fredrikstad
Country [35] 0 0
Norway
State/province [35] 0 0
Moelv
Country [36] 0 0
Norway
State/province [36] 0 0
Oslo
Country [37] 0 0
Norway
State/province [37] 0 0
Tonsberg
Country [38] 0 0
Norway
State/province [38] 0 0
Tromso
Country [39] 0 0
Norway
State/province [39] 0 0
Trondheim
Country [40] 0 0
Poland
State/province [40] 0 0
Bydgoszcz
Country [41] 0 0
Poland
State/province [41] 0 0
Katowice
Country [42] 0 0
Poland
State/province [42] 0 0
Warszawa
Country [43] 0 0
Sweden
State/province [43] 0 0
Goteborg
Country [44] 0 0
Sweden
State/province [44] 0 0
Malmo
Country [45] 0 0
Sweden
State/province [45] 0 0
Stockholm
Country [46] 0 0
Switzerland
State/province [46] 0 0
Geneve
Country [47] 0 0
Switzerland
State/province [47] 0 0
Locarno
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Birmingham
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Leeds
Country [50] 0 0
United Kingdom
State/province [50] 0 0
London
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Maidstone
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Manchester
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Newcastle
Country [54] 0 0
United Kingdom
State/province [54] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT00090363
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.
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Emerging Oncology Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00090363