A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

November 5, 2018 updated by: Janssen Research & Development, LLC

Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to collect additional safety data during treatment with abiraterone acetate plus prednisone or prednisolone among adult participants with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) who reside in areas in which abiraterone acetate is not yet available for this indication through local healthcare providers, and who are not eligible for enrollment into an available ongoing clinical study of abiraterone acetate.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

This is an open-label (identity of assigned study drug will be known) early access protocol (EAP). Approximately 60 participants will be enrolled in this study. Participants will receive abiraterone acetate 1000 mg daily plus prednisone or prednisolone 5 mg daily. Treatment in 28-day cycles will continue until progression of clinical disease. Study drug will be provided until the company obtains market authorization and reimbursement in the participant countries for this indication.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte, Brazil
      • Brasilia, Brazil
      • Florianopolis, Brazil
      • Fortaleza, Brazil
      • Jau, Brazil
      • Porto Alegre, Brazil
      • Santo Andre, Brazil
      • Sao Paulo, Brazil

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

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Not have received cytotoxic chemotherapy regimens for metastatic castration-resistant prostate cancer
  • Have prostate cancer progression as assessed by the investigator with prostate-specific antigen progression according to Prostate Cancer Working Group 2 criteria
  • Have asymptomatic or mildly symptomatic prostate cancer
  • Have ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
  • Have Eastern Cooperative Oncology Group performance status of <=2
  • Laboratory values within protocol-defined parameters
  • Adequate liver function according to protocol-defined parameters
  • Be able to swallow the study drug whole as a tablet
  • Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

  • Eligible for another study of abiraterone acetate that is open to enrollment
  • Has received abiraterone acetate in the past or was enrolled in Studies COU-AA-301 or COU-AA-302
  • Has serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Has uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg); individuals with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
  • Has active or symptomatic viral hepatitis or chronic liver disease
  • Has a history of pituitary or adrenal dysfunction
  • Has 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 Class III or IV heart disease or left ventricular ejection fraction of <50% at baseline
  • Has atrial fibrillation or other cardiac arrhythmia
  • Has known brain metastasis
  • Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of castration-resistant prostate cancer (CRPC)
  • Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
  • Has an active infection or other medical condition that would make prednisone/prednisolone use contraindicated
  • Has had other anticancer therapy including cytotoxic, radionucleotide, and immunotherapy
  • Has had prior systemic treatment with an azole drug; diethylstilbestrol; PC-SPES; spironolactone; and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer, within 4 weeks of Cycle 1 Day 1
  • Is currently enrolled in an investigational drug or device study or has participated in such a study within 30 days of Day 1
  • Has a condition or situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant's participation in the study
  • Has partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration

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?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100946
  • 212082PCR3012 (Other Identifier: Janssen Research & Development, LLC)

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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