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


Tracking Information

Start Date  ICMJEJanuary 2008
Estimated Primary Completion DateAugust 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2008)		Progression-free survival and Overall survival [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00626548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: February 21, 2008)
  • Tolerability and safety profile of ZD4054 [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
  • Health Related Quality of Life [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
  • Time to prostate-specific antigen (PSA) progression [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
  • Time to symptomatic progression [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Phase III Trial of ZD4054 (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
Official Title  ICMJEA Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients
Brief Summary

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

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

ZD4054 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 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, 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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEProstate Cancer
Intervention  ICMJE
  • Drug: ZD4054
    10 mg once daily oral dose
    Other Name: Zibotentan
  • Drug: Luteinising hormone-releasing hormone analogue (LHRHa)
    Standard acceptable dose
  • Drug: Megace
    Standard medical dose
  • Drug: Estradiol
    Standard medically acceptable dose
  • Drug: Prednisolone
    Standard medically acceptable dose
  • Drug: Ketoconazole
    Standard medically acceptable dose
  • Drug: Docetaxel
    Standard medically acceptable dose
Study Arms / Comparison Groups
  • 1: Placebo Comparator
    Existing Prostate Cancer Treatment
    Interventions:
    • Drug: Luteinising hormone-releasing hormone analogue (LHRHa)
    • Drug: Megace
    • Drug: Estradiol
    • Drug: Prednisolone
    • Drug: Ketoconazole
    • Drug: Docetaxel
  • 2: Experimental
    ZD4054 + Existing Prostate Cancer Therapy
    Interventions:
    • Drug: ZD4054
    • Drug: Luteinising hormone-releasing hormone analogue (LHRHa)
    • Drug: Megace
    • Drug: Estradiol
    • Drug: Prednisolone
    • Drug: Ketoconazole
    • Drug: Docetaxel

Recruitment Information

Estimated Enrollment  ICMJE1500
Estimated Completion DateNovember 2012
Estimated Primary Completion DateAugust 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
  • Increasing Prostate Specific Antigen (PSA) over a one month period
  • 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 opiates based pain killers) for cancer related pain
  • Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
  • Suffering from heart failure or had a myocardial infarction within last 6 months
  • A history of epilepsy or seizures
GenderMale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: AstraZeneca Cancer Study Locator Service, (US and CA only)877-400-4656astrazeneca@emergingmed.com
Contact: AstraZeneca Clinical Study Information800-236-9933information.center@astrazeneca.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Mexico,   Netherlands,   Norway,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom
 

Administrative Information

NCT ID  ICMJENCT00626548
Responsible PartyThomas Morris, BSc, MB BCh, MRCP, FFPM, ZD4054 Medical Science Director, AstraZeneca
Study ID Numbers  ICMJED4320C00015
Study Sponsor  ICMJEAstraZeneca
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Kurt Miller, Prof., M.D.Charité Campus Benjamin Franklin
Principal Investigator:Tia Higano, MDUniversity of Washington
Information Provided ByAstraZeneca