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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Placebo; Drug: ZD4054 10 mg; Drug: ZD4054 15 mg

• Registration Number: NCT00090363
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2004-08-25
• Study First Submitted QC: 2004-08-27
• Study First Posted: 2004-08-30
• Primary Completion: 2008-12
• Disposition First Submitted: 2011-05-23
• Disposition First Submitted QC: 2011-05-23
• Disposition First Posted: 2011-06-01
• Study Completion: 2011-08
• Results First Submitted: 2012-04-26
• Results First Submitted QC: 2012-08-01
• Results First Posted: 2012-09-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 447

Inclusion Criteria

• Surgically or medically castrated
• Bone metastasis
• Rising PSA

Exclusion Criteria

• Opiate use
• Prior chemotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo oral tablet once daily, with best supportive care
ZD4054 10 mg	ZD4054 10 mg	ZD4054 10 mg oral tablet once daily, with best supportive care
ZD4054 15 mg	ZD4054 15 mg	ZD4054 15 mg oral tablet once daily, with best supportive care

Primary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	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.

Secondary Outcome Measures

Name	Time	Method
Time to Death	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).	Median time (in days) from randomisation until death using the Kaplan-Meier method.
Change in Total Prostate Specific Antigen (PSA) Over Time	Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).	Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.
Objective Response Rate (ORR)	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).	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	Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.	Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.

Trial Locations

Locations (2)

Research Site; 🇬🇧 York, United Kingdom

Research site; 🇫🇷 Pontoise, France