ZD4054 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:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00090363

Purpose

This study is being carried out to see if ZD4054 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.

Condition	Intervention	Phase
Prostate Cancer	Drug: ZD4054	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 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:

To assess the effect of ZD4054 on time to progression in metastatic hormone refractory prostate cancer, which will recommend a dose of ZD4054 for use in future studies. [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to death from any cause. [ Designated as safety issue: No ]
Change in PSA over time [ Designated as safety issue: No ]
Safety and tolerability in terms of incidence and severity of adverse events and vital signs, laboratory and electrocardiogram (ECG) findings. [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]
Objective response rate in patients with measurable malignant soft tissue disease at baseline, assessed according to the RECIST criteria. [ Time Frame: assessed from baseline to progression ] [ Designated as safety issue: No ]
To obtain estimates of pharmacokinetic variables, quantify variability and explore reasons for observed variability, steady state exposure and dose and time dependency in pharmacokinetics. [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]
Change in the number of bone metastases [ Time Frame: baseline to progression ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	August 2004
Estimated Study Completion Date:	December 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Placebo ZD4054
2: Experimental ZD4054	Drug: ZD4054 Oral Tablet 10mg or 15 mg

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

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Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Emerging Oncology Medical Science Director, MD

AstraZeneca

More Information

Additional Information:

US and Canada Only This link exits the ClinicalTrials.gov site

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	D4320C00006, Trial 6, ZD4054
Study First Received:	August 25, 2004
Last Updated:	October 20, 2009
ClinicalTrials.gov Identifier:	NCT00090363 History of Changes
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:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Prostatic Diseases

Genital Neoplasms, Male
Neoplasm Metastasis
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009