A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (ENTHUSE M0)

This study has been terminated.
(early efficacy review by the Independent Data Monitoring Committee indicated it was unlikely to meet its primary efficacy endpoints)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00626548
First received: January 24, 2008
Last updated: August 29, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: ZD4054
Drug: Palcebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From date of randomization until date of death, assessed up to 33 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Health Related Quality of Life [ Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to Symptomatic Progression [ Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 2577
Study Start Date: January 2008
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching Placebo
Drug: Palcebo
Matching Plcebo oral tablet once daily
Experimental: ZD4054
ZD4054 (Zibotentan)
Drug: ZD4054
10 mg once daily oral dose
Other Name: Zibotentan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626548

  Show 330 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Kurt Miller, Prof., M.D. Charité Campus Benjamin Franklin
Principal Investigator: Tia Higano, MD University of Washington
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00626548     History of Changes
Other Study ID Numbers: D4320C00015
Study First Received: January 24, 2008
Results First Received: April 26, 2012
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Hormone Resistant Prostate Cancer
Endothelin A Receptor Antagonist
Endothelin A
Endothelin A antagonist

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014