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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01692483
Recruitment Status : Withdrawn (Sponsor determined study is not required according to PFDA Circular 2013-004)
First Posted : September 25, 2012
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):

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 Phase
Prostate Neoplasms Drug: Abiraterone acetate Drug: Prednisone Phase 4

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692483


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     History of Changes
Other Study ID Numbers: CR100856
212082PCR4003 ( Other Identifier: Janssen Pharmaceutica, Philippines )
First Posted: September 25, 2012    Key Record Dates
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
Genital Diseases, Male
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