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

Sponsored by:	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

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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)

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 2008

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

Show 60 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Emerging Oncology Medical Science Director, MD

AstraZeneca

More Information

Study ID Numbers:	D4320C00006, Trial 6, ZD4054
Study First Received:	August 25, 2004
Last Updated:	December 15, 2007
ClinicalTrials.gov Identifier:	NCT00090363
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis
Urogenital Neoplasms

Pain
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009