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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00090363
First received: August 25, 2004
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: ZD4054 15 mg
Drug: Placebo
Drug: ZD4054 10 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
447 patients with prostate cancer who had bone metastases with no pain or mild symptoms of pain and a rising serum Prostate Specific Antigen (PSA), despite a serum testosterone of <= 2.4 nmol/L (70 ng/dL), were recruited between 14th July 2004 and 10th January 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
135 of the 447 enrolled patients were not randomised to treatments groups: 126 failed screening and 9 did not meet one or more of the study inclusion or exclusion criteria.

Reporting Groups
  Description
Placebo Matching placebo oral tablet once daily, with best supportive care
ZD4054 10 mg ZD4054 10 mg oral tablet once daily, with best supportive care
ZD4054 15 mg ZD4054 15 mg oral tablet once daily, with best supportive care

Participant Flow:   Overall Study
    Placebo     ZD4054 10 mg     ZD4054 15 mg  
STARTED     107     107     98  
Received Study Treatment.     107     107     98  
COMPLETED     1 [1]   0 [1]   2 [1]
NOT COMPLETED     106     107     96  
Lost to Follow-up                 1                 2                 1  
Withdrawal by Subject                 7                 7                 6  
Study-specific discontinuation criteria                 75                 74                 62  
Eligibility criteria not fulfilled                 0                 0                 1  
Consent expired                 7                 10                 9  
Reasons not specified                 2                 1                 1  
Continuing on study off treatment                 14                 13                 16  
[1] Number of patients receiving study treatment at data cut-off (18th December 2008).



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Matching placebo oral tablet once daily, with best supportive care
ZD4054 10 mg ZD4054 10 mg oral tablet once daily, with best supportive care
ZD4054 15 mg ZD4054 15 mg oral tablet once daily, with best supportive care
Total Total of all reporting groups

Baseline Measures
    Placebo     ZD4054 10 mg     ZD4054 15 mg     Total  
Number of Participants  
[units: participants]
 		  107     107     98     312  
Age  
[units: years]
Mean ± Standard Deviation 		  71  ± 9     70  ± 8     69  ± 8     70  ± 9  
Gender  
[units: Participants]
 		       
Female     0     0     0     0  
Male     107     107     98     312  
Race/Ethnicity, Customized  
[units: Participants]
 		       
Caucasian     106     107     93     306  
Black     0     0     1     1  
Oriental     1     0     3     4  
Other     0     0     1     1  
Race/Ethnicity, Customized  
[units: Participants]
 		       
Hispanic     3     4     3     10  
African-American     0     0     1     1  
Asian     1     0     3     4  
Japanese     0     0     1     1  
Not a specific ethnic group     99     95     87     281  
Other     4     8     3     15  



  Outcome Measures
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1.  Primary:   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). ]
  Show Outcome Measure 1

2.  Secondary:   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). ]
  Show Outcome Measure 2

3.  Secondary:   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). ]
  Show Outcome Measure 3

4.  Secondary:   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). ]
  Show Outcome Measure 4

5.  Secondary:   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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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
‘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:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00090363     History of Changes
Obsolete Identifiers: NCT00107146
Other Study ID Numbers: D4320C00006, Trial 6, ZD4054
Study First Received: August 25, 2004
Results First Received: April 26, 2012
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration