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A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate

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ClinicalTrials.gov Identifier: NCT01517802
Recruitment Status : Recruiting
First Posted : January 25, 2012
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 6 years.

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Metastatic Breast Cancer Drug: Abiraterone acetate Drug: Prednisone Phase 3

Detailed Description:
This is a nonrandomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), long-term safety follow-up study of abiraterone acetate in approximately 300 patients from other completed abiraterone acetate clinical studies. Patients must have received at least 3 months of treatment with abiraterone acetate and a low-dose corticosteroid and, based on investigator assessment, may benefit from continued treatment. This study will consist of a screening period followed by open-label treatment of continued abiraterone acetate access. The patients will continue with the same abiraterone acetate and low-dose corticosteroid dosing regimen they were receiving in the previous abiraterone acetate clinical study until the investigator determines that the patient is no longer receiving benefit or the sponsor terminates the study. Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible. Each cycle of treatment will be 28 days. Investigators will monitor and assess the patients for response to treatment or progression according to routine practice or as clinically indicated to determine whether continued treatment with abiraterone acetate is warranted. No efficacy data are being collected. Safety will be monitored throughout the study for a maximum duration of 6 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study
Actual Study Start Date : March 28, 2012
Estimated Primary Completion Date : April 9, 2018
Estimated Study Completion Date : April 9, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Abiraterone acetate
Patients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study.
Drug: Abiraterone acetate
Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily
Drug: Prednisone
Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily


Outcome Measures

Primary Outcome Measures :
  1. The number of participants affected by a serious adverse event [ Time Frame: Up to 30 days after the last dose of study drug ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets.

Exclusion Criteria:

  • Medical conditions that require hospitalization.
  • Any condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517802


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 25 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01517802     History of Changes
Other Study ID Numbers: CR100797
212082PCR3010 ( Other Identifier: Janssen Research & Development, LLC )
2011-005243-28 ( EudraCT Number )
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Keywords provided by Janssen Research & Development, LLC:
Metastatic castration-resistant prostate cancer
Metastatic breast cancer
Abiraterone acetate
Low-dose corticosteroid treatment
Long-term access

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors