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

Phase 3
18 Years
Open (Enrolling)
Prostate Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male

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Trial Information

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

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.

Inclusion Criteria:

- Confirmed prostate cancer

- Prostate cancer progression after previous chemotherapy as assessed by the

- 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

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

- 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)

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number and type of adverse events reported by the investigator or the patient.

Outcome Time Frame:

From the time of signing the informed consent to the time of the End-of-Study Visit (ie, 30 days after discontinuation of study drug).

Safety Issue:


Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

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


United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

October 2014

Related Keywords:

  • Prostate Neoplasms
  • Genital Neoplasms, Male
  • Urogenital Neoplasms
  • Genital Diseases, Male
  • Metastatic Castration-Resistant Prostate Cancer (CRPC)
  • Abiraterone Acetate
  • Neoplasms
  • Genital Diseases, Male
  • Genital Neoplasms, Male
  • Prostatic Neoplasms
  • Urogenital Neoplasms



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