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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 Site Mesa, Arizona  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Hays, Kansas  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Alexandria, Minnesota  
Research Site Grand Island, Nebraska  
Research Site Las Vegas, Nevada  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Bismarck, North Dakota  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Bennington, Vermont  
Research Site Auburn, Washington  
Research Site Appleton, Wisconsin