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A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients


Inclusion Criteria:



Patients who answer TRUE to the following criteria may be eligible to participate in this
study.

- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT
spread to the other parts of the body (metastases). Patients with lymph node
involvement may be eligible if specified criteria is met.

- Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment

- Currently receiving treatment with surgical or medical castration

Exclusion Criteria:

Patients who answer TRUE to the following may NOT be eligible to participate in this
study.

- Currently using opiate based pain killers for cancer related pain

- Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior
targeted cancer therapies are permitted if received during a previous clinical trial

- Suffering from heart failure or had a myocardial infarction within last 6 months

- A history of epilepsy or seizures

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Description:

Number of participants who have died at early analysis data cut off (DCO)

Outcome Time Frame:

From date of randomization until date of death, assessed up to 33 months

Safety Issue:

No

Principal Investigator

Kurt Miller, Prof., M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Campus Benjamin Franklin

Authority:

United States: Food and Drug Administration

Study ID:

D4320C00015

NCT ID:

NCT00626548

Start Date:

January 2008

Completion Date:

May 2011

Related Keywords:

  • Prostate Cancer
  • Hormone Resistant Prostate Cancer
  • Endothelin A Receptor Antagonist
  • Endothelin A
  • Endothelin A antagonist
  • Prostatic Neoplasms

Name

Location

Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteHays, Kansas  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteAlexandria, Minnesota  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteBismarck, North Dakota  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteBennington, Vermont  
Research SiteAuburn, Washington  
Research SiteAppleton, Wisconsin