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

Overview

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).

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2008

Interventions

  • Drug: ZD4054 15 mg
    • 15 mg oral tablet once daily
  • Drug: Placebo
  • Drug: ZD4054 10 mg
    • 10mg oral tablet once daily

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Matching placebo oral tablet once daily, with best supportive care
  • Experimental: ZD4054 10 mg
    • ZD4054 10 mg oral tablet once daily, with best supportive care
  • Experimental: ZD4054 15 mg
    • ZD4054 15 mg oral tablet once daily, with best supportive care

Clinical Trial Outcome Measures

Primary 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).
    • 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 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).
    • 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).
    • 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).
    • 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.
    • Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.

Participating in This Clinical Trial

Inclusion Criteria

  • Surgically or medically castrated – Bone metastasis – Rising PSA Exclusion Criteria:

  • Opiate use – Prior chemotherapy

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • AstraZeneca Emerging Oncology Medical Science Director, MD, Study Director, AstraZeneca

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