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Trial record 9 of 640 for:    Russian Federation | Chile

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

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ClinicalTrials.gov Identifier: NCT00626548
Recruitment Status : Terminated (early efficacy review by the Independent Data Monitoring Committee indicated it was unlikely to meet its primary efficacy endpoints)
First Posted : February 29, 2008
Results First Posted : June 1, 2012
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 24, 2008
First Posted Date  ICMJE February 29, 2008
Results First Submitted Date  ICMJE April 26, 2012
Results First Posted Date  ICMJE June 1, 2012
Last Update Posted Date September 3, 2012
Study Start Date  ICMJE January 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2012)
  • 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
Original 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 ]
Change History Complete list of historical versions of study NCT00626548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
  • 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 ]
Original 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 ]
  • Health Related Quality of Life [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ]
  • 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 ]
  • Time to Symptomatic Progression [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: ZD4054
    10 mg once daily oral dose
    Other Name: Zibotentan
  • Drug: Palcebo
    Matching Plcebo oral tablet once daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching Placebo
    Intervention: Drug: Palcebo
  • Experimental: ZD4054
    ZD4054 (Zibotentan)
    Intervention: Drug: ZD4054
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 29, 2012)
2577
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2008)
1500
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date January 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). 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   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,   Serbia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Former Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00626548
Other Study ID Numbers  ICMJE D4320C00015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kurt Miller, Prof., M.D. Charite University, Berlin, Germany
Principal Investigator: Tia Higano, MD University of Washington
PRS Account AstraZeneca
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP