Prostate NeoplasmsNCT01217697
Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer
A study testing Abiraterone Acetate and Prednisone\Prednisolone in people with Prostate Neoplasms and Genital Neoplasms, Male, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 297 sites in 24 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Prostate Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms
- What is being tested?
- Abiraterone Acetate and Prednisone\Prednisolone
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 297 sitesin 24 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
297 sites in 24 countries.
297 sites in 24 countries
United States157 sites
Study site
Albany, New York
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Allentown, Pennsylvania
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Anaheim, California
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Atlanta, Georgia
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Aurora, Colorado
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Austin, Texas
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Bangor, Maine
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Bellflower, California
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Berkeley, California
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Bethany, Oklahoma
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Bettendorf, Iowa
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Beverly Hills, California
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Billings, Montana
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Binghamton, New York
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Birmingham, Alabama
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Boca Raton, Florida
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Boston, Massachusetts
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Bristol, Tennessee
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Brooklyn, New York
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Buffalo, New York
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Burlington, Vermont
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Chandler, Arizona
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Chapel Hill, North Carolina
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Charleston, South Carolina
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Charlotte, North Carolina
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Chattanooga, Tennessee
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Cherry Hill, New Jersey
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Chicago, Illinois
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Cincinnati, Ohio
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Cleveland, Ohio
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Colorado Springs, Colorado
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Columbia, South Carolina
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Columbus, Ohio
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Cooperstown, New York
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Corpus Christi, Texas
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Dallas, Texas
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Dayton, Ohio
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Dearborn, Michigan
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Decatur, Illinois
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Denver, Colorado
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Detroit, Michigan
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Duarte, California
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Dunkirk, New York
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Durham, North Carolina
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East Setauket, New York
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East Syracuse, New York
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Easton, Maryland
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Elyria, Ohio
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Encinitas, California
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Fort Collins, Colorado
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Fort Lauderdale, Florida
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Fort Myers, Florida
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Fort Wayne, Indiana
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Fresh Meadows, New York
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Gainesville, Florida
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Galveston, Texas
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Glendale, California
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Glens Falls, New York
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Grand Rapids, Michigan
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Greenbrae, California
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Greenville, North Carolina
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Greenville, South Carolina
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Hackensack, New Jersey
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Hampton, Virginia
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Hartford, Connecticut
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Harvey, Illinois
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Hendersonville, North Carolina
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High Point, North Carolina
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Honolulu, Hawaii
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Hooksett, New Hampshire
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Houston, Texas
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Huntersville, North Carolina
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La Jolla, California
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Lafayette, Indiana
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Laguna Hills, California
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Lansing, Michigan
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Las Vegas, Nevada
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Lexington, Kentucky
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Littleton, Colorado
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Livingston, New Jersey
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Long Beach, California
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Los Alamos, New Mexico
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Los Angeles, California
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Louisville, Kentucky
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Manchester, Connecticut
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Marina del Rey, California
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Marrero, Louisiana
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Massillon, Ohio
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Memphis, Tennessee
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Merrillville, Indiana
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Miami, Florida
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Middletown, Ohio
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Milwaukee, Wisconsin
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Mobile, Alabama
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Morristown, New Jersey
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Mount Kisco, New York
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Muncie, Indiana
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Myrtle Beach, South Carolina
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Nashville, Tennessee
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New Britain, Connecticut
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New Brunswick, New Jersey
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New Hyde Park, New York
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New Orleans, Louisiana
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New York, New York
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Newport News, Virginia
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Niles, Illinois
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Norfolk, Virginia
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Norwalk, Connecticut
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Norwich, Connecticut
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Ocala, Florida
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Orlando, Florida
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Palm Beach Gardens, Florida
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Paramus, New Jersey
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Peoria, Illinois
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Philadelphia, Pennsylvania
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Pinehurst, North Carolina
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Port Saint Lucie, Florida
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Portland, Oregon
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Portsmouth, New Hampshire
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Post Falls, Idaho
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Providence, Rhode Island
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Raleigh, North Carolina
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Rancho Mirage, California
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Rochester, Minnesota
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Rochester, New York
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Rockville, Maryland
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Saint Joseph, Missouri
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Saint Louis Park, Minnesota
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Salt Lake City, Utah
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San Antonio, Texas
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San Diego, California
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San Francisco, California
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Sandusky, Ohio
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Santa Rosa, California
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Savannah, Georgia
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Scarborough, Maine
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Scottsdale, Arizona
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Seattle, Washington
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South Miami, Florida
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Southington, Connecticut
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Stamford, Connecticut
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Stanford, California
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Stony Brook, New York
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Syracuse, New York
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Temple, Texas
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The Bronx, New York
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The Woodlands, Texas
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Torrington, Connecticut
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Trumball, Connecticut
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Tucson, Arizona
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Urbana, Illinois
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Washington D.C., District of Columbia
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West Reading, Pennsylvania
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Westwood, Kansas
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Worcester, Massachusetts
Australia25 sites
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Adelaide
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Bedford Park
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Box Hill
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Camperdown
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Footscray
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Garran
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Geelong
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Heidelberg
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Herston
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Hobart
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Kogarah
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Kurralta Park
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Liverpool
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Nedlands
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Port Macquarie
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Randwick
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South Brisbane
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Southport Qld
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Subiaco
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Sydney
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Tamworth
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Wahroonga
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Westmead
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Wodonga
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Woolloongabba
Canada14 sites
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Calgary
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Halifax, Nova Scotia
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Hamilton, Ontario
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Kelowna, British Columbia
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Kingston, Ontario
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London
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Montreal, Quebec
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N/a N/a
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Ottawa, Ontario
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Québec, Quebec
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Regina, Saskatchewan
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Toronto, Ontario
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Vancouver, British Columbia
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Victoria, British Columbia
Mexico13 sites
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Acapulco, Guerrero
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Aguascalientes
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Chihuahua City
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Cuernavaca
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Distrito Federal
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Durango
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Guadalajara
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León
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Mexico City
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Monterrey
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Oaxaca City
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Veracruz
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Zamora
Spain13 sites
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A Coruña
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Badajoz
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Barakaldo Vizcaya
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Barcelona
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Córdoba
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Hospitalet. Barcelona
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Madrid
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Palma de Mallorca
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Salamanca
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Santa Cruz de Tenerife
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Seville
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Toledo
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Valencia
Russia12 sites
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Barnaul
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Kazan'
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Moscow
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Nizhny Novgorod
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Obninsk
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Omsk
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Pyatigorsk
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Rostov-on-Don
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Saint Petersburg
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Stavropol
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Ufa
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Yekaterinburg
Brazil7 sites
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Belo Horizonte
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Curitiba
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Porto Alegre
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Recife
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Rio de Janeiro
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Salvador
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São Paulo
Colombia6 sites
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Bogotá
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Floridablanca
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Medellín
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Montería
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Pereira
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Valledupar
Greece6 sites
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Athens
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Athens Attica
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Crete
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Larissa
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Pátrai
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Thessalonikis
Czechia5 sites
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Brno
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Hradec Králové
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Olomouc
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Prague
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Ústí nad Labem
New Zealand5 sites
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Christchurch
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Grafton
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Hamilton
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Palmerston North
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Wellington
Poland5 sites
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Gdansk
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Lodz
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Opole
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Otwock
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Wroclaw
Malaysia4 sites
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Jalan Cheras N/A
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Kota Kinabalu
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Kuala Lumpur
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Subang Jaya
Romania4 sites
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Brasov
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Bucharest
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Cluj-Napoca
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Iași
Hong Kong3 sites
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Hong Kong
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New Territories
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Shatin
South Korea3 sites
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Hwasun Gun
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Seongnam-Si, Gyeonggi-Do
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Seoul
Taiwan3 sites
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Kaohsiung City
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Kaohsiung County
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Taoyuan
About this study
Official title: An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy
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).
Read the detailed description
This is a study to collect information on adverse events (side effects) that occur during treatment with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (CRPC). To participate in this study patients must have failed 1 or 2 chemotherapy regimens (1 of which contained a taxane such as docetaxel), reside in an area where abiraterone acetate is not yet available through local healthcare providers, and not be eligible for enrollment in any other ongoing clinical research study of abiraterone acetate. CRPC is progressive form of prostate cancer where the cancer cells become resistant to hormonal therapies that are designed to block the release or uptake of testosterone and the cancer cells metastasize (ie, spread to other parts of the body). Abiraterone acetate (referred to as abiraterone) is a drug currently under development for use in treating men with CRPC. Patients will be treated with abiraterone and prednisone daily until progression of clinical disease (ie, includes signs of clinical disease progression and/or clinical disease progression confirmed by radiographic and prostate-specific antigen [PSA] test results). Other reasons for discontinuation of treatment may include adverse events reported, initiation of other anticancer therapies, or the patient's inability to comply with dosing instructions. Patients will be followed for 30 days after the discontinuation of treatment with abiraterone acetate. Patients will take four 250-mg tablets of abiraterone orally at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day. Patients will also take 5 mg of oral prednisone, twice daily. Each treatment cycle consists of 28 days and patients will take abiraterone continually on a daily basis until disease progression is observed at which time abiraterone will be discontinued and the dose of prednisone reduced if clinically indicated.
- Being tested
- Abiraterone Acetate, Prednisone\Prednisolone
- Keywords
- Metastatic Castration-Resistant Prostate Cancer (CRPC), Abiraterone Acetate
- Medical subject headings
- Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone AcetateDrug
Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets once daily.
Prednisone\PrednisoloneDrug
Participants will receive prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg (if prednisone is not available).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217697
- Sponsor's protocol ID
- CR017479
- Other IDs
- 212082PCR3001, 2010-021425-13
- Status last verified
- Mar 2017
- First submitted
- 7 Oct 2010
- Last updated
- 24 Mar 2017
- Results posted
- No
Publications
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.
PubMed 25242048
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT01217697
- Acronym / sponsor ID
- CR017479
- Keywords
- Metastatic Castration-Resistant Prostate Cancer (CRPC), Abiraterone Acetate
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a study to collect information on adverse events (side effects) that occur during treatment with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (CRPC). To participate in this study patients must have failed 1 or 2 chemotherapy regimens (1 of which contained a taxane such as docetaxel), reside in an area where abiraterone acetate is not yet available through local healthcare providers, and not be eligible for enrollment in any other ongoing clinical research study of abiraterone acetate. CRPC is progressive form of prostate cancer where the cancer cells become resistant to hormonal therapies that are designed to block the release or uptake of testosterone and the cancer cells metastasize (ie, spread to other parts of the body). Abiraterone acetate (referred to as abiraterone) is a drug currently under development for use in treating men with CRPC. Patients will be treated with abiraterone and prednisone daily until progression of clinical disease (ie, includes signs of clinical disease progression and/or clinical disease progression confirmed by radiographic and prostate-specific antigen [PSA] test results). Other reasons for discontinuation of treatment may include adverse events reported, initiation of other anticancer therapies, or the patient's inability to comply with dosing instructions. Patients will be followed for 30 days after the discontinuation of treatment with abiraterone acetate. Patients will take four 250-mg tablets of abiraterone orally at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day. Patients will also take 5 mg of oral prednisone, twice daily. Each treatment cycle consists of 28 days and patients will take abiraterone continually on a daily basis until disease progression is observed at which time abiraterone will be discontinued and the dose of prednisone reduced if clinically indicated.
Study design
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abiraterone AcetateAbiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets once daily. | Drug | – |
| Prednisone\PrednisoloneParticipants will receive prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg (if prednisone is not available). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Derived from this study: PubMed 25242048Sternberg 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.
- An Open-Label Study of Abiraterone Acetate in Subjects with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based ChemotherapyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
297 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abiraterone Acetate and Prednisone\Prednisolone in people with Prostate Neoplasms and Genital Neoplasms, Male, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 297 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 297 sites in United States, Australia, Canada, Mexico, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01217697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.