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

Tracking Information

First Received Date ^ICMJE

August 25, 2004

Last Updated Date

October 20, 2009

Start Date ^ICMJE

August 2004

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00090363 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Time to death from any cause.
Change in PSA over time
Safety and tolerability in terms of incidence and severity of adverse events and vital signs, laboratory and electrocardiogram (ECG) findings.
Objective response rate in patients with measurable malignant soft tissue disease at baseline, assessed according to the RECIST criteria.
To obtain estimates of pharmacokinetic variables, quantify variability and explore reasons for observed variability, steady state exposure and dose and time dependency in pharmacokinetics.
Change in the number of bone metastases

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: ZD4054

Study Arms / Comparison Groups

No Intervention: Placebo ZD4054
Experimental: ZD4054

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

260

Estimated Completion Date

December 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Surgically or medically castrated
Bone metastasis
Rising PSA

Exclusion Criteria:

Opiate use
Prior chemotherapy

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada, Denmark, Finland, France, Indonesia, Netherlands, Norway, Poland, Sweden, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00090363

Responsible Party

Study ID Numbers ^ICMJE

D4320C00006, Trial 6, ZD4054

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Emerging Oncology Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP