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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ClinicalTrials.gov Identifier: NCT00090363 |
Recruitment Status :
Completed
First Posted : August 30, 2004
Results First Posted : September 3, 2012
Last Update Posted : January 8, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: ZD4054 15 mg Drug: Placebo Drug: ZD4054 10 mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 447 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | July 2004 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Matching placebo oral tablet once daily, with best supportive care
|
Drug: Placebo |
Experimental: ZD4054 10 mg
ZD4054 10 mg oral tablet once daily, with best supportive care
|
Drug: ZD4054 10 mg
10mg oral tablet once daily
Other Name: (Zibotentan) |
Experimental: ZD4054 15 mg
ZD4054 15 mg oral tablet once daily, with best supportive care
|
Drug: ZD4054 15 mg
15 mg oral tablet once daily
Other Name: Zibotentan |
- 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.
- 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). ]Median time (in days) from randomisation until death using the Kaplan-Meier method.
- 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). ]Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.
- 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). ]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 [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Surgically or medically castrated
- Bone metastasis
- Rising PSA
Exclusion Criteria:
- Opiate use
- Prior chemotherapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090363

Study Director: | AstraZeneca Emerging Oncology Medical Science Director, MD | AstraZeneca |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00090363 |
Obsolete Identifiers: | NCT00107146 |
Other Study ID Numbers: |
D4320C00006 Trial 6 ZD4054 |
First Posted: | August 30, 2004 Key Record Dates |
Results First Posted: | September 3, 2012 |
Last Update Posted: | January 8, 2013 |
Last Verified: | January 2013 |
rising PSA bone metastases Clinical study pain-free or mildly symptomatic |
Prostatic Neoplasms Neoplasm Metastasis Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Prostatic Diseases Neoplastic Processes Pathologic Processes |