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

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00090363

Purpose

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).

Condition	Intervention	Phase
Prostate Cancer	Drug: ZD4054 Drug: Placebo Drug: ZD4054 (Zibotentan)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: ZD4054

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: No ]
Change in Number of Bone Metastases over Time [ Time Frame: Baseline to last available post-baseline scan prior to discontinuation. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008) ] [ Designated as safety issue: No ]

Enrollment:	447
Study Start Date:	July 2004
Study Completion Date:	August 2011
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo ZD4054 (Zibotentan)	Drug: Placebo
Experimental: 2 ZD4054 (Zibotentan) 10mg	Drug: ZD4054 (Zibotentan) oral tablet once daily 10mg
Experimental: 3 ZD4054 (Zibotentan) 15mg	Drug: ZD4054 oral tablet once daily 15 mg Other Name: Zibotentan

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Surgically or medically castrated
Bone metastasis
Rising PSA

Exclusion Criteria:

Opiate use
Prior chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090363

Show 60 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Emerging Oncology Medical Science Director, MD

AstraZeneca

More Information

Additional Information:

Cancer Study Locator (US and Canada Only) This link exits the ClinicalTrials.gov site

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2008 Nov 29.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00090363 History of Changes
Obsolete Identifiers:	NCT00107146
Other Study ID Numbers:	D4320C00006, Trial 6, ZD4054
Study First Received:	August 25, 2004
Last Updated:	September 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

rising PSA
bone metastases
Clinical study
pain-free or mildly symptomatic

Additional relevant MeSH terms:

Neoplasm Metastasis
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male

Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on February 12, 2012