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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00554229




Registration number
NCT00554229
Ethics application status
Date submitted
2/11/2007
Date registered
6/11/2007
Date last updated
8/02/2016

Titles & IDs
Public title
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
Scientific title
A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.
Secondary ID [1] 0 0
2007-003227-20
Secondary ID [2] 0 0
D4320C00014
Universal Trial Number (UTN)
Trial acronym
ENTHUSE M1
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 - Placebo

Experimental: ZD4054 - ZD4054 10 mg oral tablet once daily

Placebo comparator: Placebo - Matching Placebo, oral tablets once daily


Treatment: Drugs: ZD4054
ZD4054 10 mg oral tablet once daily

Treatment: Drugs: Placebo
Matching placebo oral tablet once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From date of randomization until date of death, assessed up to 32 months
Secondary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months
Secondary outcome [2] 0 0
Time to Use of Opiates
Timepoint [2] 0 0
From date of randomization until use of opiates for disease-related symptoms for a duration =1 week, assessed up to 31 months
Secondary outcome [3] 0 0
Incidence of Skeletal Related Events
Timepoint [3] 0 0
From date of randomization until occurrence of a skeletal related event, assessed up to 31 months
Secondary outcome [4] 0 0
Bone Metastases Formation
Timepoint [4] 0 0
Patients were assessed every 12 weeks
Secondary outcome [5] 0 0
Health Related Quality of Life
Timepoint [5] 0 0
Patients were assessed at every visit
Secondary outcome [6] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [6] 0 0
Patients were assessed every 12 weeks
Secondary outcome [7] 0 0
Time to Pain Progression
Timepoint [7] 0 0
Patients were assessed every 12 weeks
Secondary outcome [8] 0 0
Time to Initiation of Chemotherapy
Timepoint [8] 0 0
Patients were assessed every 12 weeks
Secondary outcome [9] 0 0
Pharmacokinetic Characteristics of ZD4054
Timepoint [9] 0 0
PK samples were performed at randomisation, Week 4, Week 8 and Week 12

Eligibility
Key inclusion criteria
Patients who answer TRUE to the following criteria may be eligible to participate in this trial.

1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)
2. Increasing Prostate Specific Antigen (PSA) over a one month period
3. No pain, or mild pain from prostate cancer
4. Currently receiving treatment with surgical or medical castration
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who answer TRUE to the following may NOT eligible to participate in this trial.

1. Currently using opiates based pain killers)
2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
3. Suffering from heart failure or had a myocardial infarction within last 6 months
4. 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 assessing the outcomes
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
896
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Research Site - Hornsby
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Research Site - St Leonards
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Research Site - Redcliffe
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Research Site - Ashford
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Research Site - Subiaco
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- Hornsby
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- St Leonards
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- Redcliffe
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- Ashford
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- Subiaco
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.

* This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
* ZD4054(Zibotentan) 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 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.
* All patients participating in this clinical trial will receive existing standard 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/study/NCT00554229
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin Gleave, MD, FRCSC, FACS
Address 0 0
The Prostate Centre at Vancouver General Hospital
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/study/NCT00554229