Back to resultsZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ZD4054 15 mg
Placebo
ZD4054 10 mg
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring rising PSA, bone metastases, Clinical study, pain-free or mildly symptomatic
Eligibility Criteria
Inclusion Criteria: Surgically or medically castrated Bone metastasis Rising PSA Exclusion Criteria: Opiate use Prior chemotherapy
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
ZD4054 10 mg
ZD4054 15 mg
Arm Description
Matching placebo oral tablet once daily, with best supportive care
ZD4054 10 mg oral tablet once daily, with best supportive care
ZD4054 15 mg oral tablet once daily, with best supportive care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to Death
Median time (in days) from randomisation until death using the Kaplan-Meier method.
Change in Total Prostate Specific Antigen (PSA) Over Time
Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00090363
Brief Title
ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
rising PSA, bone metastases, Clinical study, pain-free or mildly symptomatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
447 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo oral tablet once daily, with best supportive care
Arm Title
ZD4054 10 mg
Arm Type
Experimental
Arm Description
ZD4054 10 mg oral tablet once daily, with best supportive care
Arm Title
ZD4054 15 mg
Arm Type
Experimental
Arm Description
ZD4054 15 mg oral tablet once daily, with best supportive care
Intervention Type
Drug
Intervention Name(s)
ZD4054 15 mg
Other Intervention Name(s)
Zibotentan
Intervention Description
15 mg oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
ZD4054 10 mg
Other Intervention Name(s)
(Zibotentan)
Intervention Description
10mg oral tablet once daily
Primary Outcome Measure Information:
Title
Time to Progression (TTP)
Description
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.
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).
Secondary Outcome Measure Information:
Title
Time to Death
Description
Median time (in days) from randomisation until death using the Kaplan-Meier method.
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).
Title
Change in Total Prostate Specific Antigen (PSA) Over Time
Description
Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.
Time Frame
Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).
Title
Objective Response Rate (ORR)
Description
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.
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).
Title
Change in Number of Bone Metastases Over Time
Description
Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.
Time Frame
Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Surgically or medically castrated
Bone metastasis
Rising PSA
Exclusion Criteria:
Opiate use
Prior chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Emerging Oncology Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Gainsville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Wolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Ashford
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Wodonga
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Nedlands
Country
Australia
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Arhus
Country
Denmark
Facility Name
Research Site
City
Herlev
Country
Denmark
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Joensuu
Country
Finland
Facility Name
Research Site
City
OYS
Country
Finland
Facility Name
Research Site
City
Seinäjoki
Country
Finland
Facility Name
Research Site
City
Tampere
Country
Finland
Facility Name
Research Site
City
Lille
Country
France
Facility Name
Research Site
City
Montpellier
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research site
City
Pontoise
Country
France
Facility Name
Research Site
City
Toulouse
Country
France
Facility Name
Research Site
City
Jakarta
Country
Indonesia
Facility Name
Research Site
City
Eindhoven
Country
Netherlands
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Heerlen
Country
Netherlands
Facility Name
Research Site
City
Leiden
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Utrecht
Country
Netherlands
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Fredrikstad
Country
Norway
Facility Name
Research Site
City
Moelv
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Tonsberg
Country
Norway
Facility Name
Research Site
City
Tromso
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Geneve
Country
Switzerland
Facility Name
Research Site
City
Locarno
Country
Switzerland
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Leeds
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Maidstone
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Newcastle
Country
United Kingdom
Facility Name
Research Site
City
York
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19042080
Citation
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.
Results Reference
derived
Learn more about this trial
ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
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