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

This study has been withdrawn prior to enrollment.
(Sponsor determined study is not required according to PFDA Circular 2013-004)
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01692483
First received: September 21, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica:

Primary Outcome Measures:
  • Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with disease progression [ Time Frame: Baseline up to Week 40 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692483

Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
Study Director: is Janssen Pharmaceutica, Philippines Clinical Trial Janssen Pharmaceutica, Philippines
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01692483     History of Changes
Other Study ID Numbers: CR100856, 212082PCR4003
Study First Received: September 21, 2012
Last Updated: June 24, 2013
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Janssen Pharmaceutica:
Prostate neoplasms
Prostate cancer
Castration resistant prostate cancer
Hormone refractory prostate cancer
Abiraterone acetate
Taxane

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014