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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
Trial website
Trial related presentations / publications
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

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 are available at https://clinicaltrials.gov/study/NCT00090363