Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

• Status: Approved for marketing
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Abiraterone Acetate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

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)