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A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases

NCT00554229 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 896

Last updated 2016-02-08

Study results available
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Summary

Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.

* This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
* ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.
* All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy.
* Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
* No patients will be deprived of standard prostate cancer therapy.

Conditions

Interventions

DRUG

ZD4054

ZD4054 10 mg oral tablet once daily

DRUG

Placebo

Matching placebo oral tablet once daily

Sponsors & Collaborators

Principal Investigators

  • Martin Gleave, MD, FRCSC, FACS · The Prostate Centre at Vancouver General Hospital

  • Joel B Nelson, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-07-31
Completion
2011-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Serbia
  • Singapore
  • South Africa
  • South Korea
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT00554229 on ClinicalTrials.gov