Clinical trial NCT01517802: A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
Official title: A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Castration-resistant Prostate Cancer
Metastatic Breast Cancer
Keywords: Metastatic castration-resistant prostate cancer
Metastatic breast cancer
Abiraterone acetate
Low-dose corticosteroid treatment
Long-term access
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 9 years.

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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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 9 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Marrero
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Omaha
country: United States
state: Nebraska
city: East Setauket
country: United States
state: New York
city: New York
country: United States
state: New York
city: Myrtle Beach
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Kogarah
country: Australia
city: Kurralta Park
country: Australia
city: South Brisbane
country: Australia
city: Subiaco
country: Australia
city: Antwerpen
country: Belgium
city: Hamburg
country: Germany
city: Barcelona
country: Spain
city: Uppsala
country: Sweden
city: Newcastle Upon Tyne
country: United Kingdom
city: Northwood
country: United Kingdom
city: Sutton
country: United Kingdom
city: Whitchurch
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: