Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer
An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy
3 other identifiers
expanded_access
N/A
24 countries
297
Brief Summary
The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
297 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2010
CompletedFirst Posted
Study publicly available on registry
October 8, 2010
CompletedMarch 24, 2017
March 1, 2017
October 7, 2010
March 23, 2017
Conditions
Keywords
Interventions
Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets once daily.
Participants will receive prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg (if prednisone is not available).
Eligibility Criteria
You may qualify if:
- Confirmed prostate cancer
- Prostate cancer progression after previous chemotherapy as assessed by the investigator
- Received at least 1 but not more than 2 chemotherapy regimens for metastatic CRPC (at least one regimen must have contained a taxane such as docetaxel)
- Serum testosterone of less than 50ng/dL (less than 2.0 nM)
- Eastern Cooperative Oncology Group (ECOG) performance status of \<=2 (ie, patients who do not have symptoms of prostate cancer and who are fully active, patients who have symptoms but are able to perform light work, or patients who are able to get around and are capable of taking care of themselves but are unable to carry out any work activities)
You may not qualify if:
- Serious or uncontrolled co-existent non-malignant disease (including active and uncontrolled infection)
- Active or symptomatic viral hepatitis or chronic liver disease or any abnormal liver function assessed by liver function tests
- Clinically significant heart disease as assessed by the Investigator or uncontrolled hypertension (systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=95 mmHg)
- History of gastrointestinal disorders that may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction
- Known brain metastasis (ie, spread of cancer to the brain)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (297)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Bellflower, California, United States
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Berkeley, California, United States
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Beverly Hills, California, United States
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Duarte, California, United States
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Encinitas, California, United States
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Glendale, California, United States
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Greenbrae, California, United States
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La Jolla, California, United States
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Laguna Hills, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Marina del Rey, California, United States
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Rancho Mirage, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Rosa, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Fort Collins, Colorado, United States
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Littleton, Colorado, United States
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Hartford, Connecticut, United States
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Manchester, Connecticut, United States
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New Britain, Connecticut, United States
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Norwalk, Connecticut, United States
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Norwich, Connecticut, United States
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Southington, Connecticut, United States
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Stamford, Connecticut, United States
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Torrington, Connecticut, United States
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Trumball, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Palm Beach Gardens, Florida, United States
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Port Saint Lucie, Florida, United States
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South Miami, Florida, United States
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Atlanta, Georgia, United States
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Savannah, Georgia, United States
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Honolulu, Hawaii, United States
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Post Falls, Idaho, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Harvey, Illinois, United States
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Niles, Illinois, United States
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Peoria, Illinois, United States
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Urbana, Illinois, United States
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Fort Wayne, Indiana, United States
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Lafayette, Indiana, United States
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Merrillville, Indiana, United States
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Muncie, Indiana, United States
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Bettendorf, Iowa, United States
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Westwood, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Marrero, Louisiana, United States
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New Orleans, Louisiana, United States
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Bangor, Maine, United States
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Scarborough, Maine, United States
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Easton, Maryland, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Dearborn, Michigan, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Lansing, Michigan, United States
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Rochester, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Saint Joseph, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Hooksett, New Hampshire, United States
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Portsmouth, New Hampshire, United States
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Cherry Hill, New Jersey, United States
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Hackensack, New Jersey, United States
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Livingston, New Jersey, United States
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Morristown, New Jersey, United States
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New Brunswick, New Jersey, United States
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Paramus, New Jersey, United States
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Los Alamos, New Mexico, United States
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Albany, New York, United States
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Binghamton, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Cooperstown, New York, United States
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Dunkirk, New York, United States
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East Setauket, New York, United States
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East Syracuse, New York, United States
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Fresh Meadows, New York, United States
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Glens Falls, New York, United States
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Mount Kisco, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Stony Brook, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Hendersonville, North Carolina, United States
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High Point, North Carolina, United States
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Huntersville, North Carolina, United States
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Pinehurst, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Elyria, Ohio, United States
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Massillon, Ohio, United States
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Middletown, Ohio, United States
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Sandusky, Ohio, United States
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Bethany, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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The Woodlands, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Hampton, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Adelaide, Australia
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Bedford Park, Australia
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Box Hill, Australia
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Camperdown, Australia
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Footscray, Australia
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Garran, Australia
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Geelong, Australia
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Heidelberg, Australia
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Herston, Australia
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Hobart, Australia
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Kogarah, Australia
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Kurralta Park, Australia
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Liverpool, Australia
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Nedlands, Australia
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Port Macquarie, Australia
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Randwick, Australia
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South Brisbane, Australia
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Southport Qld, Australia
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Subiaco, Australia
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Sydney, Australia
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Tamworth, Australia
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Wahroonga, Australia
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Westmead, Australia
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Wodonga, Australia
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Woolloongabba, Australia
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Belo Horizonte, Brazil
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Curitiba, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Regina, Saskatchewan, Canada
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Calgary, Canada
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London, Canada
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N/a N/a, Canada
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Bogotá, Colombia
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Floridablanca, Colombia
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Medellín, Colombia
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Montería, Colombia
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Pereira, Colombia
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Valledupar, Colombia
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Split, Croatia
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Zagreb, Croatia
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Brno, Czechia
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Hradec Králové, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Ústí nad Labem, Czechia
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Aarhus, Denmark
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Copenhagen Ø, Denmark
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Köpenhamn Ö, Denmark
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Athens, Greece
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Athens Attica, Greece
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Crete, Greece
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Larissa, Greece
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Pátrai, Greece
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Thessalonikis, Greece
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Shatin, Hong Kong
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Budapest, Hungary
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Zalaegerszeg-P Zva N/A, Hungary
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Jakarta, Indonesia
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Jalan Cheras N/A, Malaysia
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Kota Kinabalu, Malaysia
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Kuala Lumpur, Malaysia
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Subang Jaya, Malaysia
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Acapulco, Guerrero, Mexico
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Aguascalientes, Mexico
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Chihuahua City, Mexico
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Cuernavaca, Mexico
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Distrito Federal, Mexico
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Durango, Mexico
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Guadalajara, Mexico
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León, Mexico
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Mexico City, Mexico
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Monterrey, Mexico
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Oaxaca City, Mexico
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Veracruz, Mexico
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Zamora, Mexico
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Christchurch, New Zealand
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Grafton, New Zealand
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Hamilton, New Zealand
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Palmerston North, New Zealand
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Wellington, New Zealand
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Gdansk, Poland
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Lodz, Poland
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Opole, Poland
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Otwock, Poland
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Wroclaw, Poland
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Ponce, Puerto Rico
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San Juan, Puerto Rico
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Barnaul, Russia
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Kazan', Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Obninsk, Russia
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Omsk, Russia
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Pyatigorsk, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Stavropol, Russia
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Ufa, Russia
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Yekaterinburg, Russia
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Singapore, Singapore
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Hwasun Gun, South Korea
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Seongnam-Si, Gyeonggi-Do, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Badajoz, Spain
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Barakaldo Vizcaya, Spain
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Barcelona, Spain
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Córdoba, Spain
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Hospitalet. Barcelona, Spain
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Madrid, Spain
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Palma de Mallorca, Spain
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Salamanca, Spain
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Santa Cruz de Tenerife, Spain
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Seville, Spain
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Toledo, Spain
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Valencia, Spain
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Kaohsiung City, Taiwan
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Kaohsiung County, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
Related Publications (1)
Sternberg CN, Castellano D, Daugaard G, Geczi L, Hotte SJ, Mainwaring PN, Saad F, Souza C, Tay MH, Garrido JM, Galli L, Londhe A, De Porre P, Goon B, Lee E, McGowan T, Naini V, Todd MB, Molina A, George DJ; Abiraterone Global EAP Investigators. Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial. Lancet Oncol. 2014 Oct;15(11):1263-8. doi: 10.1016/S1470-2045(14)70417-6. Epub 2014 Sep 18.
PMID: 25242048DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2010
First Posted
October 8, 2010
Last Updated
March 24, 2017
Record last verified: 2017-03