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A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer

NCT00626548 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2577

Last updated 2012-09-03

Study results available
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Summary

Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.

All patients participating in this clinical trial will receive existing 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

10 mg once daily oral dose

DRUG

Palcebo

Matching Plcebo oral tablet once daily

Sponsors & Collaborators

Principal Investigators

  • Kurt Miller, Prof., M.D. · Charite University, Berlin, Germany

  • Tia Higano, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-01-31
Completion
2011-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Latvia
  • Mexico
  • Netherlands
  • Norway
  • Peru
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00626548 on ClinicalTrials.gov