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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)

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ClinicalTrials.gov Identifier: NCT00090363
Recruitment Status : Completed
First Posted : August 30, 2004
Results First Posted : September 3, 2012
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: ZD4054 15 mg Drug: Placebo Drug: ZD4054 10 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Study Start Date : July 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : August 2011

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo oral tablet once daily, with best supportive care
 Drug: Placebo
Experimental: ZD4054 10 mg
ZD4054 10 mg oral tablet once daily, with best supportive care
 Drug: ZD4054 10 mg
10mg oral tablet once daily
Other Name: (Zibotentan)
Experimental: ZD4054 15 mg
ZD4054 15 mg oral tablet once daily, with best supportive care
 Drug: ZD4054 15 mg
15 mg oral tablet once daily
Other Name: Zibotentan


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


Secondary Outcome Measures :
  1. 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). ]
    Median time (in days) from randomisation until death using the Kaplan-Meier method.

  2. 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). ]
    Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.

  3. 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). ]
    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.

  4. 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. ]
    Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgically or medically castrated
  • Bone metastasis
  • Rising PSA

Exclusion Criteria:

  • Opiate use
  • Prior chemotherapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090363


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Emerging Oncology Medical Science Director, MD AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00090363    
Obsolete Identifiers: NCT00107146
Other Study ID Numbers: D4320C00006
Trial 6
ZD4054
First Posted: August 30, 2004    Key Record Dates
Results First Posted: September 3, 2012
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
rising PSA
bone metastases
Clinical study
pain-free or mildly symptomatic
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Prostatic Diseases
Neoplastic Processes
Pathologic Processes