ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)

January 3, 2013 updated by: AstraZeneca

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Nedlands, Australia
        • Research Site
    • Queensland
      • Wolloongabba, Queensland, Australia
        • Research Site
    • South Australia
      • Ashford, South Australia, Australia
        • Research Site
    • Victoria
      • Wodonga, Victoria, Australia
        • Research Site
  • Belgium
      • Brussels, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Ontario
      • London, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • Denmark
      • Arhus, Denmark
        • Research Site
      • Herlev, Denmark
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Joensuu, Finland
        • Research Site
      • OYS, Finland
        • Research Site
      • Seinäjoki, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
  • France
      • Lille, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Paris, France
        • Research Site
      • Pontoise, France
        • Research Site
      • Toulouse, France
        • Research Site
  • Indonesia
      • Jakarta, Indonesia
        • Research Site
  • Netherlands
      • Eindhoven, Netherlands
        • Research Site
      • Groningen, Netherlands
        • Research Site
      • Heerlen, Netherlands
        • Research Site
      • Leiden, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Utrecht, Netherlands
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Fredrikstad, Norway
        • Research Site
      • Moelv, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Tonsberg, Norway
        • Research Site
      • Tromso, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
  • Poland
      • Bydgoszcz, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Sweden
      • Goteborg, Sweden
        • Research Site
      • Malmo, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
  • Switzerland
      • Geneve, Switzerland
        • Research Site
      • Locarno, Switzerland
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Research Site
      • Leeds, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Maidstone, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Newcastle, United Kingdom
        • Research Site
      • York, United Kingdom
        • Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Los Angeles, California, United States
        • Research Site
    • Florida
      • Gainsville, Florida, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States
        • Research Site
    • South Carolina
      • Simpsonville, South Carolina, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Surgically or medically castrated
  • Bone metastasis
  • Rising PSA

Exclusion Criteria:

  • Opiate use
  • Prior chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • (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 Names:
  • Zibotentan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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.
Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
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.
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).
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.
Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Emerging Oncology Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 25, 2004

First Submitted That Met QC Criteria

August 27, 2004

First Posted (Estimate)

August 30, 2004

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4320C00006
  • Trial 6
  • ZD4054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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