A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases (ENTHUSE M1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00554229
First received: November 2, 2007
Last updated: August 29, 2012
Last verified: April 2012
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: ZD4054
Drug: Placebo

  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
896 patients with hormone-resistant prostate cancer patients and bone metastasis were recruited between 20th November 2007 and 13th February 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
302 of the 896 enrolled patients were not randomised to treatments groups as they failed screening.

Reporting Groups
  Description
ZD4054 ZD4054 10 mg oral tablet once daily
Placebo Placebo oral tablet once daily

Participant Flow:   Overall Study
    ZD4054     Placebo  
STARTED     299     295  
Patients Who Received Treatment     298     295  
COMPLETED     73     70  
NOT COMPLETED     226     225  
Lost to Follow-up                 3                 6  
Withdrawal by Subject                 29                 37  
Adverse Event                 71                 39  
Protocol Violation                 3                 3  
Reason not otherwise captured, eg; death                 119                 140  
Randomised but no treatment received                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ZD4054 ZD4054 10 mg oral tablet once daily
Placebo Placebo oral tablet once daily
Total Total of all reporting groups

Baseline Measures
    ZD4054     Placebo     Total  
Number of Participants  
[units: participants]
  299     295     594  
Age  
[units: Years]
Mean ± Standard Deviation
     
Overall     70.2  ± 7.8     70.9  ± 8.6     70.5  ± 8.2  
Gender  
[units: Participants]
     
Female     0     0     0  
Male     299     295     594  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From date of randomization until date of death, assessed up to 32 months ]

2.  Secondary:   Progression Free Survival   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months ]

3.  Secondary:   Time to Use of Opiates   [ Time Frame: From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months ]

4.  Secondary:   Incidence of Skeletal Related Events   [ Time Frame: From date of randomization until occurrence of a skeletal related event, assessed up to 31 months ]

5.  Secondary:   Bone Metastases Formation   [ Time Frame: Patients were assessed every 12 weeks ]

6.  Secondary:   Health Related Quality of Life   [ Time Frame: Patients were assessed at every visit ]

7.  Secondary:   Time to Prostate-specific Antigen (PSA) Progression   [ Time Frame: Patients were assessed every 12 weeks ]

8.  Secondary:   Time to Pain Progression   [ Time Frame: Patients were assessed every 12 weeks ]

9.  Secondary:   Time to Initiation of Chemotherapy   [ Time Frame: Patients were assessed every 12 weeks ]

10.  Secondary:   Pharmacokinetic Characteristics of ZD4054   [ Time Frame: PK samples were performed at randomisation, Week 4, Week 8 and Week 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00554229     History of Changes
Obsolete Identifiers: NCT00707395
Other Study ID Numbers: D4320C00014, 2007-003227-20
Study First Received: November 2, 2007
Results First Received: April 26, 2012
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration