A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
Study Details
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 9 years.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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 9 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.
Study Design
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
- 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.
Eligibility Criteria
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Aurora | Colorado | United States | ||
2 | Marrero | Louisiana | United States | ||
3 | Boston | Massachusetts | United States | ||
4 | Omaha | Nebraska | United States | ||
5 | East Setauket | New York | United States | ||
6 | New York | New York | United States | ||
7 | Myrtle Beach | South Carolina | United States | ||
8 | Chattanooga | Tennessee | United States | ||
9 | Dallas | Texas | United States | ||
10 | Houston | Texas | United States | ||
11 | Kogarah | Australia | |||
12 | Kurralta Park | Australia | |||
13 | South Brisbane | Australia | |||
14 | Subiaco | Australia | |||
15 | Antwerpen | Belgium | |||
16 | Hamburg | Germany | |||
17 | Barcelona | Spain | |||
18 | Uppsala | Sweden | |||
19 | Newcastle Upon Tyne | United Kingdom | |||
20 | Northwood | United Kingdom | |||
21 | Sutton | United Kingdom | |||
22 | Whitchurch | United Kingdom |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.- CR100797
- 212082PCR3010
- 2011-005243-28
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Out of 32 randomized participants, 1 participant did not receive any dose of drug and hence was excluded from all the analyses. |
Arm/Group Title | Abiraterone Acetate + Prednisone/Prednisolone |
---|---|
Arm/Group Description | 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. |
Period Title: Overall Study | |
STARTED | 31 |
COMPLETED | 30 |
NOT COMPLETED | 1 |
Baseline Characteristics
Arm/Group Title | Abiraterone Acetate + Prednisone/Prednisolone |
---|---|
Arm/Group Description | 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. |
Overall Participants | 31 |
Age, Customized (Count of Participants) | |
63-90 years |
31
100%
|
Sex: Female, Male (Count of Participants) | |
Female |
0
0%
|
Male |
31
100%
|
Race and Ethnicity Not Collected (Count of Participants) |
Outcome Measures
Title | Number of Participants With Serious Adverse Events (SAEs) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Safety analysis set included participants that received at least 1 dose of study drug. |
Arm/Group Title | Abiraterone Acetate + Prednisone/Prednisolone |
---|---|
Arm/Group Description | 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. |
Measure Participants | 31 |
Count of Participants [Participants] |
16
51.6%
|
Adverse Events
Time Frame | Up to 9 years | |
---|---|---|
Adverse Event Reporting Description | Safety analysis set included participants who received at least 1 dose of study drug. | |
Arm/Group Title | Abiraterone Acetate + Prednisone/Prednisolone | |
Arm/Group Description | 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. | |
All Cause Mortality |
||
Abiraterone Acetate + Prednisone/Prednisolone | ||
Affected / at Risk (%) | # Events | |
Total | 1/31 (3.2%) | |
Serious Adverse Events |
||
Abiraterone Acetate + Prednisone/Prednisolone | ||
Affected / at Risk (%) | # Events | |
Total | 16/31 (51.6%) | |
Cardiac disorders | ||
Cardiac Failure | 1/31 (3.2%) | |
Cardiac Failure Congestive | 1/31 (3.2%) | |
Myocardial Infarction | 1/31 (3.2%) | |
Gastrointestinal disorders | ||
Diarrhoea | 2/31 (6.5%) | |
Nausea | 1/31 (3.2%) | |
Oesophagitis | 1/31 (3.2%) | |
Vomiting | 1/31 (3.2%) | |
General disorders | ||
Fatigue | 1/31 (3.2%) | |
Infections and infestations | ||
Lower Respiratory Tract Infection | 1/31 (3.2%) | |
Urinary Tract Infection | 1/31 (3.2%) | |
Injury, poisoning and procedural complications | ||
Fall | 2/31 (6.5%) | |
Skin Laceration | 2/31 (6.5%) | |
Upper Limb Fracture | 1/31 (3.2%) | |
Investigations | ||
Weight Decreased | 1/31 (3.2%) | |
Metabolism and nutrition disorders | ||
Dehydration | 1/31 (3.2%) | |
Musculoskeletal and connective tissue disorders | ||
Musculoskeletal Pain | 1/31 (3.2%) | |
Nervous system disorders | ||
Cerebrovascular Accident | 1/31 (3.2%) | |
Encephalopathy | 1/31 (3.2%) | |
Spinal Cord Compression | 1/31 (3.2%) | |
Syncope | 1/31 (3.2%) | |
Renal and urinary disorders | ||
Acute Kidney Injury | 1/31 (3.2%) | |
Urinary Retention | 1/31 (3.2%) | |
Respiratory, thoracic and mediastinal disorders | ||
Dyspnoea | 1/31 (3.2%) | |
Pulmonary Embolism | 3/31 (9.7%) | |
Surgical and medical procedures | ||
Aortic Valve Replacement | 1/31 (3.2%) | |
Vascular disorders | ||
Aortic Thrombosis | 1/31 (3.2%) | |
Hypertension | 1/31 (3.2%) | |
Other (Not Including Serious) Adverse Events |
||
Abiraterone Acetate + Prednisone/Prednisolone | ||
Affected / at Risk (%) | # Events | |
Total | 0/31 (0%) | |
Cardiac disorders | ||
Cardiac Failure | 0/31 (0%) | |
Cardiac Failure Congestive | 0/31 (0%) | |
Myocardial Infarction | 0/31 (0%) | |
Gastrointestinal disorders | ||
Diarrhoea | 0/31 (0%) | |
Nausea | 0/31 (0%) | |
Oesophagitis | 0/31 (0%) | |
Vomiting | 0/31 (0%) | |
General disorders | ||
Fatigue | 0/31 (0%) | |
Infections and infestations | ||
Lower Respiratory Tract Infection | 0/31 (0%) | |
Urinary Tract Infection | 0/31 (0%) | |
Injury, poisoning and procedural complications | ||
Fall | 0/31 (0%) | |
Skin Laceration | 0/31 (0%) | |
Upper Limb Fracture | 0/31 (0%) | |
Investigations | ||
Weight Decreased | 0/31 (0%) | |
Metabolism and nutrition disorders | ||
Dehydration | 0/31 (0%) | |
Musculoskeletal and connective tissue disorders | ||
Musculoskeletal Pain | 0/31 (0%) | |
Nervous system disorders | ||
Cerebrovascular Accident | 0/31 (0%) | |
Encephalopathy | 0/31 (0%) | |
Spinal Cord Compression | 0/31 (0%) | |
Syncope | 0/31 (0%) | |
Renal and urinary disorders | ||
Acute Kidney Injury | 0/31 (0%) | |
Urinary Retention | 0/31 (0%) | |
Respiratory, thoracic and mediastinal disorders | ||
Dyspnoea | 0/31 (0%) | |
Pulmonary Embolism | 0/31 (0%) | |
Surgical and medical procedures | ||
Aortic Valve Replacement | 0/31 (0%) | |
Vascular disorders | ||
Aortic Thrombosis | 0/31 (0%) | |
Hypertension | 0/31 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | DIRECTOR CLINICAL RESEARCH |
---|---|
Organization | Janssen Research & Development, LLC |
Phone | 844-434-4210 |
ClinicalTrialDisclosure@its.jnj.com |
- CR100797
- 212082PCR3010
- 2011-005243-28