ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090363
• Other study ID #: D4320C00006
• Secondary ID: Trial 6ZD4054
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2004
• Last updated: January 3, 2013
• Start date: July 2004
• Est. completion date: August 2011

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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).

Other known NCT identifiers

• NCT00107146

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: August 2011
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Surgically or medically castrated

• Bone metastasis

• Rising PSA

Exclusion Criteria:

• Opiate use

• Prior chemotherapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ZD4054 15 mg
15 mg oral tablet once daily
• Placebo

• ZD4054 10 mg
10mg oral tablet once daily

Locations

Country	Name	City	State
Australia	Research Site	Ashford	South Australia
Australia	Research Site	Nedlands
Australia	Research Site	Wodonga	Victoria
Australia	Research Site	Wolloongabba	Queensland
Belgium	Research Site	Brussels
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Canada	Research site	London	Ontario
Canada	Research site	Montreal	Quebec
Canada	Research site	Quebec
Canada	Research site	Toronto	Ontario
Canada	Research site	Vancouver	British Columbia
Denmark	Research Site	Arhus
Denmark	Research Site	Herlev
Finland	Research Site	Helsinki
Finland	Research Site	Joensuu
Finland	Research Site	OYS
Finland	Research Site	Seinäjoki
Finland	Research Site	Tampere
France	Research Site	Lille
France	Research Site	Montpellier
France	Research Site	Paris
France	Research site	Pontoise
France	Research Site	Toulouse
Indonesia	Research Site	Jakarta
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Groningen
Netherlands	Research Site	Heerlen
Netherlands	Research Site	Leiden
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Utrecht
Norway	Research Site	Bergen
Norway	Research Site	Fredrikstad
Norway	Research Site	Moelv
Norway	Research Site	Oslo
Norway	Research Site	Tonsberg
Norway	Research Site	Tromso
Norway	Research Site	Trondheim
Poland	Research Site	Bydgoszcz
Poland	Research Site	Katowice
Poland	Research Site	Warszawa
Sweden	Research Site	Goteborg
Sweden	Research Site	Malmo
Sweden	Research Site	Stockholm
Switzerland	Research Site	Geneve
Switzerland	Research Site	Locarno
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	London
United Kingdom	Research Site	Maidstone
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Newcastle
United Kingdom	Research Site	York
United States	Research Site	Baltimore	Maryland
United States	Research Site	Chicago	Illinois
United States	Research Site	Cleveland	Ohio
United States	Research Site	Gainsville	Florida
United States	Research Site	Los Angeles	California
United States	Research Site	Simpsonville	South Carolina
United States	Research Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  Finland,  France,  Indonesia,  Netherlands,  Norway,  Poland,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	No
Secondary	Time to Death	Median time (in days) from randomisation until death using the Kaplan-Meier method.	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).	No
Secondary	Change in Total Prostate Specific Antigen (PSA) Over Time	Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.	Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).	No
Secondary	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.	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).	No
Secondary	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.	Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.	No

External Links

•   Cancer Study Locator (US and Canada Only)