Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00638690
First received: March 13, 2008
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.


Condition Intervention Phase
Prostatic Neoplasms
Drug: Placebo
Drug: Abiraterone acetate
Drug: Prednisone/prednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Cougar Biotechnology, Inc.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.


Secondary Outcome Measures:
  • Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.

  • Number of Patients Achieving a Prostate-Specific Antigen Decline >=50% [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.

  • Radiographic Progression-free Survival [ Time Frame: Up to 11 months ] [ Designated as safety issue: No ]
    Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.


Enrollment: 1195
Study Start Date: May 2008
Study Completion Date: October 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abiraterone acetate plus prednisone/prednisolone Drug: Abiraterone acetate
Four 250-mg tablets once daily until disease progression
Drug: Prednisone/prednisolone
5 mg twice daily until disease progression
Placebo Comparator: Placebo plus prednisone/prednisolone Drug: Placebo
Four tablets once daily until disease progression
Drug: Prednisone/prednisolone
5 mg twice daily until disease progression

Detailed Description:

Abiraterone acetate is a steroidal irreversible inhibitor of CYP17 (17α hydroxylase/C17, 20-lyase), blocking 2 important enzymatic activities in the synthesis of testosterone. The goal of this study is to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens, one of which contains docetaxel. All patients involved in the study will be randomized (assigned by chance) into one of two arms and will not know what study drug is being given to them. Study drug randomization allocation will be 2:1 (abiraterone acetate: placebo). The study will be conducted in the United States, Canada, Australia, and the EU. The study will consist of screening, treatment, and follow-up. In this study, patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until progression of clinical disease. Follow-up will continue until patient dies, is lost to follow-up, or withdraws informed consent. After providing written informed consent, patients will have screening procedures completed to determine eligibility. Safety evaluations at the screening procedure will include a physical examination, vital signs, and clinical blood laboratory tests, ECG, radiographs, urine tests, and recording of any adverse events including details of current prostate cancer symptoms. Patients will be asked to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.

Study medication, abiraterone acetate,is an oral (by mouth) medication to be administered as four (4) 250mg abiraterone acetate tablets or 4 placebo tablets to be taken at least one hour before or two hours after a meal anytime up to 10PM everyday. Prednisone will be administered as 5mg orally twice a day for both groups. Each cycle will be 28 days. Study treatment will continue until disease progression as determined by investigator or when the patient meets criteria for withdrawal from study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior cytotoxic chemotherapies
  • At least one chemotherapy must have contained docetaxel
  • Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2
  • Medical or surgical castration with testosterone < 50 ng/dL
  • Adequate bone marrow, hepatic and renal function
  • Potassium >= 3.5 mmol/L
  • Able to swallow the study drug whole as a tablet
  • Informed Consent

Exclusion Criteria:

  • More than two prior cytotoxic chemotherapy regimens
  • Prior Ketoconazole for prostate cancer
  • Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
  • Uncontrolled hypertension
  • Active or symptomatic viral hepatitis or chronic liver disease
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease
  • Other malignancy
  • Known brain metastasis
  • GI disorder affecting absorption
  • Not willing to use contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638690

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Beverly Hills, California, United States
Duarte, California, United States
Los Angeles, California, United States
Marina Del Rey, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Connecticut
Bristol, Connecticut, United States
New Haven, Connecticut, United States
Stamford, Connecticut, United States
United States, Florida
Boca Raton, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
West Palm Beach, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Illinois
Chicago, Illinois, United States
Galesburg, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Westwood, Kansas, United States
Wichita, Kansas, United States
United States, Louisiana
Marrero, Louisiana, United States
New Orleans, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, Minnesota
Robbinsdale, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Montana
Billings, Montana, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Box 302, New York, United States
East Setauket, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Stony Brook, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Raleigh, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
Cincinnati, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Myrtle Beach, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Virgiania Beach, Virginia, United States
United States, Washington
Seattle, Washington, United States
Australia
Adelaide, Australia
Camperdown, Australia
Footscray, Australia
Geelong, Australia
Heidelberg, Australia
Herston, Australia
Hobart, Australia
Hornsby, Australia
Kogarah, Australia
Kurralta Park, Australia
Liverpool, Australia
Milton, Australia
Parkville, Australia
Perth, Australia
Subiaco, Australia
Wodonga, Australia
Wollongong, Australia
Austria
Linz, Austria
Salzburg, Austria
Wien, Austria
Belgium
Antwerpen, Belgium
Bonheiden, Belgium
Bruxelles, Belgium
Gent, Belgium
Hasselt, Belgium
Kortrijk, Belgium
Leuven, Belgium
Liege, Belgium
Roeselare, Belgium
Canada, Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Canada, Saskatchewan
Regina, Saskatchewan, Canada
Canada
Calgary Ab, Canada
London, Canada
France
Angers Cedex 01, France
Caen, France
Cannes, France
Dijon, France
Lyon, France
Paris, France
Saint Herblain, France
Vandoeuvre Les Nancy Cedex, France
Villejuif N/A, France
Germany
Aachen, Germany
Berlin, Germany
Dresden, Germany
Hamburg, Germany
Homburg/Saar, Germany
Hungary
Pecs, Hungary
Szombathely, Hungary
Ireland
Cork, Ireland
Dublin, Ireland
Dublin 7, Ireland
Netherlands
Nijmegen, Netherlands
Spain
Badalona, Spain
Barcelona, Spain
Madrid, Spain
United Kingdom
Belfast, United Kingdom
Birmingham, United Kingdom
Cambridge, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Newcastle Upon Tyne, United Kingdom
Northwood, United Kingdom
Oxford, United Kingdom
Sutton, United Kingdom
Whitchurch, United Kingdom
Sponsors and Collaborators
Cougar Biotechnology, Inc.
Investigators
Study Director: Cougar Biotechnology, Inc Clinical Trial Cougar Biotechnology, Inc.
  More Information

No publications provided by Cougar Biotechnology, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00638690     History of Changes
Other Study ID Numbers: CR016924, COU-AA-301
Study First Received: March 13, 2008
Results First Received: August 23, 2011
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Australia: National Health and Medical Research Council
Canada: Health Canada

Keywords provided by Cougar Biotechnology, Inc.:
Metastatic Castration-Resistant Prostate Cancer
CRPC
Abiraterone Acetate
CB7630

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisone
Prednisolone hemisuccinate
Prednisolone phosphate
Docetaxel
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 23, 2014