Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

APPROVED_FOR_MARKETING

Conditions studied: Prostate Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male

In brief

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).

Key facts

Study ID

NCT01217697

Run by

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

Last updated by the study team

2017-03-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Bellflower, California, United States
• Study site — Berkeley, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Duarte, California, United States
• Study site — Encinitas, California, United States
• Study site — Glendale, California, United States
• Study site — Greenbrae, California, United States
• Study site — La Jolla, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Marina del Rey, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Stanford, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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