A Phase III Trial of ZD4054 (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer (ENTHUSEM1C)


Tracking Information

Start Date  ICMJEJanuary 2008
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 6, 2008)		Overall survival [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00617669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 6, 2008)
  • Progression free survival [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
  • Tolerability and safety profile of ZD4054 [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of skeletal related events [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
  • Time to prostate-specific antigen (PSA) progression [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
  • Time to pain progression [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
  • Pain response [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
  • Health Related Quality of Life [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 weeks ] [ Designated as safety issue: No ]
  • PSA response [ Time Frame: while receving docetaxel study visits will be aligned with its adminstration ie every 3 weeks, after 12 weeks and completion of docetaxel therapy study may be every 12 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) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
Official Title  ICMJEA Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
Brief Summary

Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 can further improve survival compared with docetaxel alone.

ZD4054 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 in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.

All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.

Half the patients will receive ZD4054, and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further 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: Docetaxel
    intravenous infusion given every three weeks
    Other Name: Taxotere®
  • Drug: ZD4054
    10 mg oral once daily dose
    Other Name: Zibotentan
Study Arms / Comparison Groups
  • 1: Active Comparator
    docetaxel monotherapy
    Intervention: Drug: Docetaxel
  • 2: Experimental
    docetaxel + ZD4054
    Interventions:
    • Drug: Docetaxel
    • Drug: ZD4054

Recruitment Information

Estimated Enrollment  ICMJE1044
Estimated Completion DateMarch 2012
Estimated Primary Completion DateMarch 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 trial.

  • Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)
  • 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 ARE NOT eligible to participate in this trial.

  • 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,   Brazil,   Canada,   Czech Republic,   Finland,   France,   Germany,   Hungary,   India,   Italy,   Korea, Republic of,   Netherlands,   Norway,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00617669
Responsible PartyThomas Morris, BSc, MB BCh, MRCP, FFPM, ZD4054 Medical Science Director, AstraZeneca
Study ID Numbers  ICMJED4320C00033
Study Sponsor  ICMJEAstraZeneca
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Karim Fizazi, MD, PhDInstitut Gustave Roussy
Principal Investigator:Judd W Moul, MD, FACSDuke University
Information Provided ByAstraZeneca