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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)

NCT00090363 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2013-01-08

Study results available
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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).

Conditions

Interventions

DRUG

ZD4054 15 mg

15 mg oral tablet once daily

DRUG

Placebo

DRUG

ZD4054 10 mg

10mg oral tablet once daily

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Emerging Oncology Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2008-12-31
Completion
2011-08-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Indonesia
  • Netherlands
  • Norway
  • Poland
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00090363 on ClinicalTrials.gov