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Trial record 9 of 647 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

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: ZD4054 Drug: Palcebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2577 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)

  2. 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 Outcome Measures :
  1. Health Related Quality of Life [ Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks ]
  2. 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 ]
  3. Time to Symptomatic Progression [ Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626548


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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Kurt Miller, Prof., M.D. Charite University, Berlin, Germany
Principal Investigator: Tia Higano, MD University of Washington

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00626548     History of Changes
Other Study ID Numbers: D4320C00015
First Posted: February 29, 2008    Key Record Dates
Results First Posted: June 1, 2012
Last Update Posted: September 3, 2012
Last Verified: April 2012
Keywords provided by AstraZeneca:
Hormone Resistant Prostate Cancer
Endothelin A Receptor Antagonist
Endothelin A
Endothelin A antagonist
Additional relevant MeSH terms:
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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