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

• ClinicalTrials.gov Identifier: NCT01692483
• Recruitment Status: Withdrawn
• First Posted: September 25, 2012
• Last Update Posted: December 2, 2015
• Sponsor: Janssen Pharmaceutica
• Information provided by (Responsible Party): Janssen Pharmaceutica

Study Description

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.

Condition or disease	Intervention/treatment
Prostate Neoplasms	Drug: Abiraterone acetate; Drug: Prednisone

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer
• Study Start Date: July 2013
• Estimated Primary Completion Date: June 2016
• Estimated Study Completion Date: June 2016

Groups and Cohorts

Group/Cohort	Intervention/treatment
Abiraterone acetate plus prednisone	Drug: Abiraterone acetate; Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily; Drug: Prednisone; Prednisone or prednisolone 5 mg tablet taken orally twice daily

Outcome Measures

Primary Outcome Measures :

1. Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ]

Secondary Outcome Measures :

1. Number of patients with disease progression [ Time Frame: Baseline up to Week 40 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Male Filipino patients with advanced metastatic castration resistant prostate cancer

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

Contacts and Locations

Sponsors and Collaborators

Janssen Pharmaceutica

Investigators

• Study Director: is Janssen Pharmaceutica, Philippines Clinical Trial; Janssen Pharmaceutica, Philippines

More Information

• Responsible Party: Janssen Pharmaceutica
• ClinicalTrials.gov Identifier: NCT01692483
• Other Study ID Numbers: CR100856; 212082PCR4003 ( Other Identifier: Janssen Pharmaceutica, Philippines )
• First Posted: September 25, 2012
• Last Update Posted: December 2, 2015
• Last Verified: November 2015

Keywords provided by Janssen Pharmaceutica:

Prostate neoplasms; Prostate cancer; Castration resistant prostate cancer; Hormone refractory prostate cancer; Abiraterone acetate; Taxane

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Prednisone; Abiraterone Acetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors