Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01517802




Registration number
NCT01517802
Ethics application status
Date submitted
23/01/2012
Date registered
25/01/2012
Date last updated
10/05/2022

Titles & IDs
Public title
A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
Scientific title
A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study
Secondary ID [1] 0 0
212082PCR3010
Secondary ID [2] 0 0
CR100797
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Cancer 0 0
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Prednisone

Experimental: Abiraterone acetate - Patients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study.


Treatment: Drugs: Abiraterone acetate
Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily

Treatment: Drugs: Prednisone
Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to 9 years

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/04/2021
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Kogarah
Recruitment hospital [2] 0 0
- Kurralta Park
Recruitment hospital [3] 0 0
- South Brisbane
Recruitment hospital [4] 0 0
- Subiaco
Recruitment postcode(s) [1] 0 0
- Kogarah
Recruitment postcode(s) [2] 0 0
- Kurralta Park
Recruitment postcode(s) [3] 0 0
- South Brisbane
Recruitment postcode(s) [4] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Germany
State/province [10] 0 0
Hamburg
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Sweden
State/province [12] 0 0
Uppsala
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Newcastle Upon Tyne
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Northwood
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Sutton
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Whitchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01517802
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01517802