Clinical trial · Observational
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
NCT01692483CI-TRIAL-00019996withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor determined study is not required according to PFDA Circular 2013-004
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Neoplasms | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Abiraterone acetate plus prednisone
- interventionNames
- Drug: Abiraterone acetate
- Drug: Prednisone
Primary outcomes (1)
- measure
- Number of participants affected by an adverse event
- timeFrame
- Up to 30 days after the last dose of study medication
Secondary outcomes (1)
- measure
- Number of patients with disease progression
- timeFrame
- Baseline up to Week 40
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.