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

Overview

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.

Full Title of Study: “A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: January 2011

Interventions

  • Drug: ZD4054
    • 10 mg once daily oral dose
  • Drug: Palcebo
    • Matching Plcebo oral tablet once daily

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Matching Placebo
  • Experimental: ZD4054
    • ZD4054 (Zibotentan)

Clinical Trial Outcome Measures

Primary Measures

  • Overall Survival
    • Time Frame: From date of randomization until date of death, assessed up to 33 months
    • Number of participants who have died at early analysis data cut off (DCO)
  • Progression Free Survival
    • Time Frame: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
    • Number of participants who have a progression event at the early analysis DCO, 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

Secondary Measures

  • Health Related Quality of Life
    • Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
  • Time to Prostate-specific Antigen (PSA) Progression
    • Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
  • Time to Symptomatic Progression
    • Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks

Participating in This Clinical Trial

Inclusion Criteria

Patients who answer TRUE to the following criteria may be eligible to participate in this study.

  • Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
  • Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
  • Currently receiving treatment with surgical or medical castration

Exclusion Criteria

Patients who answer TRUE to the following may NOT be eligible to participate in this study.

  • Currently using opiate based pain killers for cancer related pain
  • Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
  • Suffering from heart failure or had a myocardial infarction within last 6 months
  • A history of epilepsy or seizures

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)
    • Kurt Miller, Prof., M.D., Principal Investigator, Charite University, Berlin, Germany
    • Tia Higano, MD, Principal Investigator, University of Washington

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.