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Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer

Phase 4
18 Years
Not Enrolling
Prostate Neoplasms

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Trial Information

Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer

This is an open-label (identity of assigned study drug will be known), observational study
to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with
advanced metastatic CRPC who have received prior chemotherapy containing a taxane.
Approximately 50 patients will be enrolled. Abiraterone acetate will be administered
according to the approved product insert with a low-dose glucocorticoid (prednisone or
prednisolone). Patient assessments will be based on the accepted clinical practice in the
Philippines. Patients will be monitored for 40 weeks.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell histology

- Received at least 1 but not more than 2 cytotoxic chemotherapy regimens for
metastatic castration resistant prostate cancer (CRPC) (at least 1 regimen must have
contained a taxane such as docetaxel; if a chemotherapy regimen containing a taxane
is used more than once, this will be considered as 1 regimen)

- Agrees to protocol-defined use of effective contraception

- Laboratory values within protocol -defined parameters

Exclusion Criteria:

- Serious or uncontrolled co-existent non-malignant disease, including active and
uncontrolled infection

- Abnormal liver function

- Uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood
pressure >=95 mmHg)

- Active or symptomatic viral hepatitis or chronic liver disease

- History of pituitary or adrenal dysfunction

- Clinically significant heart disease as evidenced by myocardial infarction, or
arterial thrombotic events in the past 6 months, severe or unstable angina, or New
York Heart Association (NYHA) Class III or IV heart disease or left ventricular
ejection fraction of <50% at baseline

- Known brain metastasis

- History of gastrointestinal disorders (medical disorders or extensive surgery) that
may interfere with the absorption of the study drug

- Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved
to a NCI-CTCAE (Version 4.0) Grade of <=1

- Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole,
ketoconazole) within 4 weeks of Cycle 1, Day 1

- Condition or situation which, in the investigator's opinion, may put the patient at
significant risk, may confound the study results, or may interfere significantly with
patient's participation in the study

- Participation in an investigational drug trial within 30 days prior to selection

- Known hypersensitivity to abiraterone acetate, or to any of the components in the

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of participants affected by an adverse event

Outcome Time Frame:

Up to 30 days after the last dose of study medication

Safety Issue:


Principal Investigator

is Janssen Pharmaceutica, Philippines Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Pharmaceutica, Philippines


Philippines: Bureau of Food and Drugs

Study ID:




Start Date:

June 2013

Completion Date:

June 2016

Related Keywords:

  • Prostate Neoplasms
  • Prostate neoplasms
  • Prostate cancer
  • Castration resistant prostate cancer
  • Hormone refractory prostate cancer
  • Abiraterone acetate
  • Taxane
  • Neoplasms
  • Prostatic Neoplasms