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
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: ZD4054 15 mg
Drug: Placebo
Drug: ZD4054 10 mg
Phase 2

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
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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:
  • 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). ] [ Designated as safety issue: No ]
    Median time (in days) from randomisation until death using the Kaplan-Meier method.

  • 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). ] [ Designated as safety issue: No ]
    Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.

  • 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). ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.


Enrollment: 447
Study Start Date: July 2004
Study Completion Date: August 2011
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090363

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Locations
United States, Arizona
Research Site
Tucson, Arizona, United States
United States, California
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Los Angeles, California, United States
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Gainsville, Florida, United States
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Cleveland, Ohio, United States
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Wodonga, Victoria, Australia
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Tampere, Finland
France
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Maidstone, United Kingdom
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Manchester, United Kingdom
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Newcastle, United Kingdom
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York, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Emerging Oncology Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by AstraZeneca:
rising PSA
bone metastases
Clinical study
pain-free or mildly symptomatic

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014