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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00626548




Registration number
NCT00626548
Ethics application status
Date submitted
24/01/2008
Date registered
29/02/2008
Date last updated
3/09/2012

Titles & IDs
Public title
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
Scientific 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
Secondary ID [1] 0 0
D4320C00015
Universal Trial Number (UTN)
Trial acronym
ENTHUSE M0
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZD4054
Treatment: Drugs - Palcebo

Placebo Comparator: Placebo - Matching Placebo

Experimental: ZD4054 - ZD4054 (Zibotentan)


Treatment: Drugs: ZD4054
10 mg once daily oral dose

Treatment: Drugs: Palcebo
Matching Plcebo oral tablet once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival - Number of participants who have died at early analysis data cut off (DCO)
Timepoint [1] 0 0
From date of randomization until date of death, assessed up to 33 months
Primary outcome [2] 0 0
Progression Free Survival - 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
Timepoint [2] 0 0
Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
Secondary outcome [1] 0 0
Health Related Quality of Life
Timepoint [1] 0 0
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Secondary outcome [2] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [2] 0 0
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Secondary outcome [3] 0 0
Time to Symptomatic Progression
Timepoint [3] 0 0
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - Hornsby
Recruitment hospital [3] 0 0
Research Site - Westmead
Recruitment hospital [4] 0 0
Research Site - Wollongong
Recruitment hospital [5] 0 0
Research Site - Wodonga
Recruitment hospital [6] 0 0
Research Site - Nedlands
Recruitment hospital [7] 0 0
Research Site - Sydney
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Hornsby
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- Westmead
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- Wollongong
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- Wodonga
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- Nedlands
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment outside Australia
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Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00626548
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kurt Miller, Prof., M.D.
Address 0 0
Charite University, Berlin, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00626548