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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01517802
Collaborator
(none)
32
22
1
108.8
1.5
0

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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
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 :
Mar 28, 2012
Actual Primary Completion Date :
Apr 22, 2021
Actual Study Completion Date :
Apr 22, 2021

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. 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

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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.

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.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01517802
Other Study ID Numbers:
  • CR100797
  • 212082PCR3010
  • 2011-005243-28
First Posted:
Jan 25, 2012
Last Update Posted:
May 10, 2022
Last Verified:
Apr 1, 2022

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

1. Primary Outcome
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

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.

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
Email ClinicalTrialDisclosure@its.jnj.com
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01517802
Other Study ID Numbers:
  • CR100797
  • 212082PCR3010
  • 2011-005243-28
First Posted:
Jan 25, 2012
Last Update Posted:
May 10, 2022
Last Verified:
Apr 1, 2022