The purpose of this study is to collect additional safety information on abirateroneacetate administered with prednisone to patients with metastatic castration-resistantprostate cancer (CRPC).
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.
Drug: Abiraterone Acetate
Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4
tablets once daily.
Drug: Prednisone\Prednisolone
Participants will receive prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg
(if prednisone is not available).
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Birmingham, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Bellflower, California, United States
Berkeley, California, United States
Beverly Hills, California, United States
Duarte, California, United States
Encinitas, California, United States
Glendale, California, United States
Greenbrae, California, United States
La Jolla, California, United States
Laguna Hills, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Marina Del Rey, California, United States
Rancho Mirage, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Rosa, California, United States
Stanford, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Littleton, Colorado, United States
Hartford, Connecticut, United States
Manchester, Connecticut, United States
New Britain, Connecticut, United States
Norwalk, Connecticut, United States
Norwich, Connecticut, United States
Southington, Connecticut, United States
Stamford, Connecticut, United States
Torrington, Connecticut, United States
Trumball, Connecticut, United States
Washington, District of Columbia, United States
Boca Raton, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Palm Beach Gardens, Florida, United States
Port Saint Lucie, Florida, United States
South Miami, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Honolulu, Hawaii, United States
Post Falls, Idaho, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Harvey, Illinois, United States
Niles, Illinois, United States
Peoria, Illinois, United States
Urbana, Illinois, United States
Fort Wayne, Indiana, United States
Lafayette, Indiana, United States
Merrillville, Indiana, United States
Muncie, Indiana, United States
Bettendorf, Iowa, United States
Westwood, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Marrero, Louisiana, United States
New Orleans, Louisiana, United States
Bangor, Maine, United States
Scarborough, Maine, United States
Easton, Maryland, United States
Rockville, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Dearborn, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Lansing, Michigan, United States
Rochester, Minnesota, United States
Saint Louis Park, Minnesota, United States
St. Joseph, Missouri, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Hooksett, New Hampshire, United States
Portsmouth, New Hampshire, United States
Cherry Hill, New Jersey, United States
Hackensack, New Jersey, United States
Livingston, New Jersey, United States
Morristown, New Jersey, United States
New Brunswick, New Jersey, United States
Paramus, New Jersey, United States
Los Alamos, New Mexico, United States
Albany, New York, United States
Binghamton, New York, United States
Bronx, New York, United States
Brooklyn, New York, United States
Buffalo, New York, United States
Cooperstown, New York, United States
Dunkirk, New York, United States
East Setauket, New York, United States
East Syracuse, New York, United States
Fresh Meadows, New York, United States
Glens Falls, New York, United States
Mt. Kisco, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Rochester, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Hendersonville, North Carolina, United States
High Point, North Carolina, United States
Huntersville, North Carolina, United States
Pinehurst, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Elyria, Ohio, United States
Massillon, Ohio, United States
Middletown, Ohio, United States
Sandusky, Ohio, United States
Bethany, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
West Reading, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Myrtle Beach, South Carolina, United States
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
The Woodlands, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Hampton, Virginia, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Adelaide, Australia
Bedford Park, Australia
Box Hill, Australia
Camperdown, Australia
Footscray, Australia
Garran, Australia
Geelong, Australia
Heidelberg, Australia
Herston, Australia
Hobart, Australia
Kogarah, Australia
Kurralta Park, Australia
Liverpool, Australia
Nedlands, Australia
Port Macquarie, Australia
Randwick, Australia
South Brisbane, Australia
Southport Qld, Australia
Subiaco, Australia
Sydney, Australia
Tamworth, Australia
Wahroonga, Australia
Westmead, Australia
Wodonga, Australia
Woolloongabba, Australia
Belo Horizonte, Brazil
Curitiba, Brazil
Porto Alegre, Brazil
Recife, Brazil
Rio De Janeiro, Brazil
Salvador, Brazil
Sao Paulo, Brazil
São Paulo, Brazil
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Regina, Saskatchewan, Canada
Calgary, Canada
London, Canada
N/a N/a, Canada
Quebec, Canada
Bogota, Colombia
Floridablanca, Colombia
Medellin, Colombia
Monteria, Colombia
Pereira, Colombia
Valledupar, Colombia
Split, Croatia
Zagreb, Croatia
Brno, Czech Republic
Hradec Kralove, Czech Republic
Olomouc, Czech Republic
Praha 2, Czech Republic
Usti Nad Labem, Czech Republic
Aarhus, Denmark
Copenhagen Ø, Denmark
Köpenhamn Ö, Denmark
Athens Attica, Greece
Athens, Greece
Crete, Greece
Larisa, Greece
Patra, Greece
Thessalonikis, Greece
Hk, Hong Kong
Hong Kong, Hong Kong
New Territories, Hong Kong
Sha Tin, Hong Kong
Budapest N/A, Hungary
Budapest, Hungary
Zalaegerszeg-P Zva N/A, Hungary
Jakarta, Indonesia
Hwasun Gun, Korea, Republic of
Seongnam-Si, Gyeonggi-Do, Korea, Republic of
Seoul, Korea, Republic of
Jalan Cheras N/A, Malaysia
Kota Kinabalu, Malaysia
Kuala Lumpur N/A, Malaysia
Kuala Lumpur, Malaysia
Subang Jaya, Malaysia
Acapulco, Guerrero, Mexico
Aguascalientes, Mexico
Chihuahua, Mexico
Ciudad De Mexico, Mexico
Cuernavaca, Mexico
Distrito Federal, Mexico
Durango, Mexico
Guadalajara, Mexico
Leon, Mexico
Mexico City, Mexico
Mexico, D.F., Mexico
Monterrey, Mexico
Oaxaca, Mexico
Veracruz, Mexico
Zamora, Mexico
Christchurch, New Zealand
Grafton, New Zealand
Hamilton, New Zealand
Palmerston North, New Zealand
Wellington, New Zealand
Gdansk, Poland
Lodz, Poland
Opole, Poland
Otwock, Poland
Wroclaw, Poland
Ponce, Puerto Rico
San Juan, Puerto Rico
Brasov, Romania
Bucuresti, Romania
Cluj-Napoca, Romania
Iasi, Romania
Barnaul, Russian Federation
Ekaterinburg, Russian Federation
Kazan, Russian Federation
Moscow, Russian Federation
Nizhny Novgorod, Russian Federation
Obninsk, Russian Federation
Omsk, Russian Federation
Pyatigorsk, Russian Federation
Rostov-On-Don, Russian Federation
Saint-Petersburg, Russian Federation
St Petersburg, Russian Federation
St-Petersburg, Russian Federation
Stavropol, Russian Federation
Ufa, Russian Federation
Singapore, Singapore
Badajoz, Spain
Barakaldo Vizcaya, Spain
Barcelona, Spain
Cordoba, Spain
Hospitalet. Barcelona, Spain
La Coruña, Spain
Madrid, Spain
Palma De Mallorca, Spain
Salamanca, Spain
Santa Cruz De Tenerife, Spain
Sevilla, Spain
Toledo, Spain
Valencia, Spain
Kaohsiung County, Taiwan
Kaohsiung, Taiwan
Taoyuan, Taiwan
Bangkok, Thailand
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.