Metastatic Breast Cancer, Metastatic Castration-resistant Prostate Cancer
Conditions
Keywords
Metastatic castration-resistant prostate cancer, Metastatic breast cancer, Abiraterone acetate, Low-dose corticosteroid treatment, Long-term access
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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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.
Interventions
DRUGAbiraterone acetate
Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily
DRUGPrednisone
Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | Up to 9 years | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. |
Countries
Australia, Belgium, Germany, Spain, Sweden, United Kingdom, United States
Participant flow
Pre-assignment details
Out of 32 randomized participants, 1 participant did not receive any dose of drug and hence was excluded from all the analyses.
Participants by arm
| Arm | Count |
|---|---|
| Abiraterone Acetate + Prednisone/Prednisolone Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 \[NCT00473512\], COU-AA-002 \[NCT00473746\], COU-AA-006 \[NCT00910754\], COU-AA-206 \[NCT01400555\], COU-AA-301 \[NCT00638690\], COU-AA-302 \[NCT00887198\], COU-AA-BMA \[NCT00544440\]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Abiraterone Acetate + Prednisone/Prednisolone | — |
|---|---|---|
| Age, Customized 63-90 years | 31 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 31 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 16 / 31 |
Outcome results
Primary
Number of Participants With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.
Time frame: Up to 9 years
Population: Safety analysis set included participants that received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abiraterone Acetate + Prednisone/Prednisolone | Number of Participants With Serious Adverse Events (SAEs) | 16 Participants |