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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)


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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)


Inclusion Criteria:



- Surgically or medically castrated

- Bone metastasis

- Rising PSA

Exclusion Criteria:

- Opiate use

- Prior chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to Progression (TTP)

Outcome Description:

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.

Outcome 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).

Safety Issue:

No

Principal Investigator

AstraZeneca Emerging Oncology Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D4320C00006

NCT ID:

NCT00090363

Start Date:

July 2004

Completion Date:

August 2011

Related Keywords:

  • Prostate Cancer
  • rising PSA
  • bone metastases
  • Clinical study
  • pain-free or mildly symptomatic
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteArlington Heights, Illinois  
Research SiteBaltimore, Maryland  
Research SiteAkron, Ohio  
Research SiteCharleston, South Carolina