Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

NCT ID: NCT01217697

Last Updated: 2017-03-24

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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).

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.

Conditions

Prostate Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male

Interventions

Abiraterone Acetate

Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets once daily.

Intervention Type: DRUG

Prednisone\Prednisolone

Participants will receive prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg (if prednisone is not available).

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Hartford, Connecticut, United States

Manchester, Connecticut, United States

New Britain, Connecticut, United States

Norwalk, Connecticut, United States

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

Norwich, Connecticut, United States

Southington, Connecticut, United States

Stamford, Connecticut, United States

Torrington, Connecticut, United States

Trumball, Connecticut, United States

Washington D.C., 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

Saint 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

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

Mount 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

The Bronx, 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

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

Québec, Quebec, Canada

Regina, Saskatchewan, Canada

Calgary, , Canada

London, , Canada

N/a N/a, , Canada

Bogotá, , Colombia

Floridablanca, , Colombia

Medellín, , Colombia

Montería, , Colombia

Pereira, , Colombia

Valledupar, , Colombia

Split, , Croatia

Zagreb, , Croatia

Brno, , Czechia

Hradec Králové, , Czechia

Olomouc, , Czechia

Prague, , Czechia

Ústí nad Labem, , Czechia

Aarhus, , Denmark

Copenhagen Ø, , Denmark

Köpenhamn Ö, , Denmark

Athens, , Greece

Athens Attica, , Greece

Crete, , Greece

Larissa, , Greece

Pátrai, , Greece

Thessalonikis, , Greece

Hong Kong, , Hong Kong

New Territories, , Hong Kong

Shatin, , Hong Kong

Budapest, , Hungary

Zalaegerszeg-P Zva N/A, , Hungary

Jakarta, , Indonesia

Jalan Cheras N/A, , Malaysia

Kota Kinabalu, , Malaysia

Kuala Lumpur, , Malaysia

Subang Jaya, , Malaysia

Acapulco, Guerrero, , Mexico

Aguascalientes, , Mexico

Chihuahua City, , Mexico

Cuernavaca, , Mexico

Distrito Federal, , Mexico

Durango, , Mexico

Guadalajara, , Mexico

León, , Mexico

Mexico City, , Mexico

Monterrey, , Mexico

Oaxaca City, , 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

Bucharest, , Romania

Cluj-Napoca, , Romania

Iași, , Romania

Barnaul, , Russia

Kazan', , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Obninsk, , Russia

Omsk, , Russia

Pyatigorsk, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Stavropol, , Russia

Ufa, , Russia

Yekaterinburg, , Russia

Singapore, , Singapore

Hwasun Gun, , South Korea

Seongnam-Si, Gyeonggi-Do, , South Korea

Seoul, , South Korea

A Coruña, , Spain

Badajoz, , Spain

Barakaldo Vizcaya, , Spain

Barcelona, , Spain

Córdoba, , Spain

Hospitalet. Barcelona, , Spain

Madrid, , Spain

Palma de Mallorca, , Spain

Salamanca, , Spain

Santa Cruz de Tenerife, , Spain

Seville, , Spain

Toledo, , Spain

Valencia, , Spain

Kaohsiung City, , Taiwan

Kaohsiung County, , Taiwan

Taoyuan District, , Taiwan

Bangkok, , Thailand

Countries

United States; Australia; Brazil; Canada; Colombia; Croatia; Czechia; Denmark; Greece; Hong Kong; Hungary; Indonesia; Malaysia; Mexico; New Zealand; Poland; Puerto Rico; Romania; Russia; Singapore; South Korea; Spain; Taiwan; Thailand

References

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.

Reference Type: DERIVED

PMID: 25242048 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=867&filename=CR017479_CSR.pdf

An Open-Label Study of Abiraterone Acetate in Subjects with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy

Other Identifiers

212082PCR3001

Identifier Type: OTHER

Identifier Source: secondary_id

2010-021425-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR017479

Identifier Type: -

Identifier Source: org_study_id