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

PHRR120921-000007

212082PCR4003

Unspecified

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.

Start Date Duration in Months Target Completion Date Actual Completion Date
2013-06-01 36 2016-06-01 0000-00-00

Suspended

The company decided to cancel this study, as per FDA circular FDA 2013-004.

Institution Classification Region LTO #
Janssen Pharmaceuticals, Inc. Private Business NCR
Institution Region
Janssen Pharmaceuticals, Inc. NCR
Name E-Mail Phone Number Postal Address
Erwin G. Benedicto, MD ebenedic@its.jnj.com 632 8248935 Janssen Pharmaceutical Companies of Johnson and Johnson Philippines Inc., Edison Road, Barrio Ibayo, 1700 Paranaque City, Philippines
Name E-Mail Phone Number Postal Address
Erwin G. Benedicto, MD ebenedic@its.jnj.com 632 8248935 Janssen Pharmaceutical Companies of Johnson and Johnson Philippines Inc., Edison Road, Barrio Ibayo, 1700 Paranaque City, Philippines
Name Expertise Affiliation
Not applicable Not applicable TBD
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
TBD Not applicable Not applicable Not applicable
Project Location Institutional Ethics Review Board
TBD TBD

Clinical Trial

Unspecified

Prostate Neoplasms

Number of participants affected by an adverse event, Up to 30 days after the last dose of study medication, Y.

Number of patients with disease progression, Baseline up to Week 40, N.

Suspended

  • Philippines

212082PCR4003

Unspecified

Unspecified

0000-00-00

Protocol Code Number 212082PCR4003
Protocol Version Unspecified
Date of Protocol Version Unspecified

50

Unspecified

TBD - Not yet started

Unspecified

01 Jun 2013

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 NCICTCAE (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.

Observational

Unspecified

Unspecified

None

Method of Allocation

Non-randomized

Masking or Blinding

Open-label

Masking Details

Unspecified

Control

Unspecified

Assignment

Single Arm

Phase

Phase IV

Purpose of the Study

Conducted after the national drug registration authority (i.e. FDA) has approved a drug for distribution or marketing.

Detailed purpose of the study

Unspecified

Plan to Share IPD

Unspecified

IPD Description

Unspecified

Date of posting of result summaries

Unspecified

Date of the first journal publication of results

Unspecified

URL hyperlinks related to results and publications

Unspecified

URL link to protocol files(s) with version and data

Unspecified

Baseline Characteristics

Unspecified

Participant Flow

Unspecified

Adverse Events

Unspecified

Outcome Measures

Unspecified

Brief Summary

Unspecified

Utilization Utilization Info
No records found.
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