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Completed

NCT Number: NCT00090363

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Wolloongabba, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgically or medically castrated
  • Bone metastasis
  • Rising PSA

Exclusion criteria

  • Opiate use
  • Prior chemotherapy

Treatment and study plan

ZD4054 15 mg

Drug

15 mg oral tablet once daily

Other names: Zibotentan

Placebo

Drug

ZD4054 10 mg

Drug

10mg oral tablet once daily

Other names: (Zibotentan)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2008
Study completion
2011
First posted
Aug 30, 2004
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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