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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR3010 | Other Identifier | Janssen Research & Development, LLC | |
| 2011-005243-28 | EudraCT Number |
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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.
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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate | Experimental | Patients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug | Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 9 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora | Colorado | United States | ||||
Out of 32 randomized participants, 1 participant did not receive any dose of drug and hence was excluded from all the analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2015 |
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| Prednisone | Drug | Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily |
|
| Marrero |
| Louisiana |
| United States |
| Boston | Massachusetts | United States |
| Omaha | Nebraska | United States |
| East Setauket | New York | United States |
| New York | New York | United States |
| Myrtle Beach | South Carolina | United States |
| Chattanooga | Tennessee | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Kogarah | Australia |
| Kurralta Park | Australia |
| South Brisbane | Australia |
| Subiaco | Australia |
| Antwerp | Belgium |
| Hamburg | Germany |
| Barcelona | Spain |
| Uppsala | Sweden |
| Newcastle upon Tyne | United Kingdom |
| Northwood | United Kingdom |
| Sutton | United Kingdom |
| Whitchurch | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis set included participants that received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 9 years |
|
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|
Up to 9 years
Safety analysis set included participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 31 | 16 | 31 | 0 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Aortic Thrombosis | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Aortic Valve Replacement | Surgical and medical procedures | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Spinal Cord Compression | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Aortic Thrombosis | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Weight Decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Aortic Valve Replacement | Surgical and medical procedures | MedDRA Version 23.0 | Non-systematic Assessment |
|
No site qualification or initiation visits conducted for previous studies on abiraterone acetate. No formal case report forms were developed nor clinical database was generated to capture data in this study. Due to disease condition, most of participants were lost to follow-up and hence data collected was not as planned. Data were recorded based on available source notes at participating sites and thereby into CIOMS. Studied population was very small hence it was difficult to generalize results.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DIRECTOR CLINICAL RESEARCH | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Apr 20, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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