Prostate CancerPhase 2NCT00090363
ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
A Phase 2 study testing ZD4054 15 mg and ZD4054 10 mg in people with Prostate Cancer, run by AstraZeneca at 60 sites in 14 countries.
Trial summary
This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ZD4054 15 mg and ZD4054 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 447 participants
- Where
- 60 sitesin 14 countries
- Study dates
- Jul 2004to Aug 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgically or medically castrated
- Bone metastasis
- Rising PSA
Who cannot join
- Opiate use
- Prior chemotherapy
Trial locations and contacts
60 sites in 14 countries.
60 sites in 14 countries
United States7 sites
Research Site
Baltimore, Maryland
Research Site
Chicago, Illinois
Research Site
Cleveland, Ohio
Research Site
Gainsville, Florida
Research Site
Los Angeles, California
Research Site
Simpsonville, South Carolina
Research Site
Tucson, Arizona
Norway7 sites
Research Site
Bergen
Research Site
Fredrikstad
Research Site
Moelv
Research Site
Oslo
Research Site
Tønsberg
Research Site
Tromsø
Research Site
Trondheim
United Kingdom7 sites
Research Site
Birmingham
Research Site
Leeds
Research Site
London
Research Site
Maidstone
Research Site
Manchester
Research Site
Newcastle
Research Site
York
Netherlands6 sites
Research Site
Eindhoven
Research Site
Groningen
Research Site
Heerlen
Research Site
Leiden
Research Site
Rotterdam
Research Site
Utrecht
Canada5 sites
Research site
London, Ontario
Research site
Montreal, Quebec
Research site
Québec, Quebec
Research site
Toronto, Ontario
Research site
Vancouver, British Columbia
Finland5 sites
Research Site
Helsinki
Research Site
Joensuu
Research Site
OYS
Research Site
Seinäjoki
Research Site
Tampere
France5 sites
Research Site
Lille
Research Site
Montpellier
Research Site
Paris
Research site
Pontoise
Research Site
Toulouse
Australia4 sites
Research Site
Ashford, South Australia
Research Site
Nedlands
Research Site
Wodonga, Victoria
Research Site
Wolloongabba, Queensland
Poland3 sites
Research Site
Bydgoszcz
Research Site
Katowice
Research Site
Warsaw
Sweden3 sites
Research Site
Gothenburg
Research Site
Malmö
Research Site
Stockholm
About this study
Official title: Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).
- Conditions
- Prostate Cancer
- Being tested
- ZD4054 15 mg, Placebo, ZD4054 10 mg
- Keywords
- rising PSA, bone metastases, Clinical study, pain-free or mildly symptomatic
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD4054 15 mgDrug
Also called Zibotentan
15 mg oral tablet once daily
PlaceboDrug
ZD4054 10 mgDrug
Also called (Zibotentan)
10mg oral tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo oral tablet once daily, with best supportive care Receives: Drug: Placebo |
| ZD4054 10 mg | Experimental | ZD4054 10 mg oral tablet once daily, with best supportive care Receives: Drug: ZD4054 10 mg |
| ZD4054 15 mg | Experimental | ZD4054 15 mg oral tablet once daily, with best supportive care Receives: Drug: ZD4054 15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression (TTP)
Median time (in days) from randomisation until disease progression, 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 or death using the Kaplan-Meier method.
Measured: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).
Secondary outcomes (4)
Time to Death
Median time (in days) from randomisation until death using the Kaplan-Meier method.
Measured: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).
Change in Total Prostate Specific Antigen (PSA) Over Time
Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.
Measured: Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
Objective Response Rate (ORR)
Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST. Objective Response Rate (ORR) is defined as the percentage of patients with OR.
Measured: For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
Change in Number of Bone Metastases Over Time
Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.
Measured: Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2004 (estimated)
- Study startJul 2004
- Primary completionDec 2008
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca Emerging Oncology Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090363
- Sponsor's protocol ID
- D4320C00006
- Other IDs
- Trial 6, ZD4054
- Status last verified
- Jan 2013
- First submitted
- 25 Aug 2004
- Last updated
- 8 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
James ND, Caty A, Borre M, Zonnenberg BA, Beuzeboc P, Morris T, Phung D, Dawson NA. Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: a double-blind, placebo-controlled, randomised, phase 2 trial. Eur Urol. 2009 May;55(5):1112-23. doi: 10.1016/j.eururo.2008.11.002. Epub 2008 Nov 29.
PubMed 19042080
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
- ClinicalTrials.gov ID
- NCT00090363
- Acronym / sponsor ID
- D4320C00006
- Conditions
- Prostate Cancer
- Keywords
- rising PSA, bone metastases, Clinical study, pain-free or mildly symptomatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Aug 2004 (estimated)
- Results
- Posted 3 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo oral tablet once daily, with best supportive care |
| ZD4054 10 mg | Experimental | Drug: ZD4054 10 mgZD4054 10 mg oral tablet once daily, with best supportive care |
| ZD4054 15 mg | Experimental | Drug: ZD4054 15 mgZD4054 15 mg oral tablet once daily, with best supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgically or medically castrated
- Bone metastasis
- Rising PSA
Key exclusion criteria (2 listed)
- Opiate use
- Prior chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD4054 15 mgAlso: Zibotentan15 mg oral tablet once daily | Drug | ZD4054 15 mg |
| Placebo | Drug | Placebo |
| ZD4054 10 mgAlso: (Zibotentan)10mg oral tablet once daily | Drug | ZD4054 10 mg |
Primary outcome
Time to Progression (TTP)
Time frame: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).
Median time (in days) from randomisation until disease progression, 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 or death using the Kaplan-Meier method.
4 secondary outcomes
Time to Death
Time frame: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).
Change in Total Prostate Specific Antigen (PSA) Over Time
Time frame: Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
Objective Response Rate (ORR)
Time frame: For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
Change in Number of Bone Metastases Over Time
Time frame: Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19042080James ND, Caty A, Borre M, Zonnenberg BA, Beuzeboc P, Morris T, Phung D, Dawson NA. Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: a double-blind, placebo-controlled, randomised, phase 2 trial. Eur Urol. 2009 May;55(5):1112-23. doi: 10.1016/j.eururo.2008.11.002. Epub 2008 Nov 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Emerging Oncology Medical Science Director, MD study director
AstraZeneca
60 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZD4054 15 mg and ZD4054 10 mg in people with Prostate Cancer, run by AstraZeneca at 60 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Norway, United Kingdom, Netherlands, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Progression (TTP) (time frame: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00090363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.