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

NCT ID: NCT01692483

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Prostate Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Abiraterone acetate plus prednisone

Abiraterone acetate

Intervention Type DRUG

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

Prednisone

Intervention Type DRUG

Prednisone or prednisolone 5 mg tablet taken orally twice daily

Interventions

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Abiraterone acetate

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

Intervention Type DRUG

Prednisone

Prednisone or prednisolone 5 mg tablet taken orally twice daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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is Janssen Pharmaceutica, Philippines Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica, Philippines

Other Identifiers

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212082PCR4003

Identifier Type: OTHER

Identifier Source: secondary_id

CR100856

Identifier Type: -

Identifier Source: org_study_id