- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692483
Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Advanced Metastatic Castration Resistant Prostate Cancer
November 30, 2015 updated by: Janssen Pharmaceutica
Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Male Filipino patients with advanced metastatic castration resistant prostate cancer
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Abiraterone acetate plus prednisone
|
Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
Prednisone or prednisolone 5 mg tablet taken orally twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants affected by an adverse event
Time Frame: Up to 30 days after the last dose of study medication
|
Up to 30 days after the last dose of study medication
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with disease progression
Time Frame: Baseline up to Week 40
|
Baseline up to Week 40
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: is Janssen Pharmaceutica, Philippines Clinical Trial, Janssen Pharmaceutica, Philippines
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
September 21, 2012
First Submitted That Met QC Criteria
September 21, 2012
First Posted (Estimate)
September 25, 2012
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Prednisone
- Abiraterone Acetate
Other Study ID Numbers
- CR100856
- 212082PCR4003 (Other Identifier: Janssen Pharmaceutica, Philippines)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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