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A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer


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

Thank you

Trial Information

A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer


Inclusion Criteria:



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

- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has
spread to the bone (bone metastasis)

- 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 ARE NOT eligible to participate in this trial.

- 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:

Median time (in months) from randomisation until death using the Kaplan-Meier method.

Outcome Time Frame:

Patients were followed for survival up to 40 months

Safety Issue:

No

Principal Investigator

Karim Fizazi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

United States: Food and Drug Administration

Study ID:

D4320C00033

NCT ID:

NCT00617669

Start Date:

January 2008

Completion Date:

July 2011

Related Keywords:

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

Name

Location
Research Site Anaheim, California  
Research Site Danbury, Connecticut  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Baltimore, Maryland  
Research Site Alexandria, Minnesota  
Research Site Grand Island, Nebraska  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Abington, Virginia  
Research Site Auburn, Washington  
Research Site Appleton, Wisconsin