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

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

Sponsors

Lead Sponsor: Janssen Pharmaceutica

Source Janssen Pharmaceutica
Brief Summary

The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy containing a taxane.

Detailed Description

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.

Overall Status Withdrawn
Start Date July 2013
Completion Date June 2016
Primary Completion Date June 2016
Study Type Observational
Primary Outcome
Measure Time Frame
Number of participants affected by an adverse event Up to 30 days after the last dose of study medication
Secondary Outcome
Measure Time Frame
Number of patients with disease progression Baseline up to Week 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: Abiraterone acetate

Description: Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily

Arm Group Label: Abiraterone acetate plus prednisone

Intervention Type: Drug

Intervention Name: Prednisone

Description: Prednisone or prednisolone 5 mg tablet taken orally twice daily

Arm Group Label: Abiraterone acetate plus prednisone

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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 formulation

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
is Janssen Pharmaceutica, Philippines Clinical Trial Study Director Janssen Pharmaceutica, Philippines
Verification Date

November 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Abiraterone acetate plus prednisone

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov