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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01217697




Registration number
NCT01217697
Ethics application status
Date submitted
7/10/2010
Date registered
8/10/2010
Date last updated
24/03/2017

Titles & IDs
Public title
Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer
Scientific title
An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy
Secondary ID [1] 0 0
212082PCR3001
Secondary ID [2] 0 0
CR017479
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Neoplasms 0 0
Genital Neoplasms, Male 0 0
Urogenital Neoplasms 0 0
Genital Diseases, Male 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Other cancer types
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cancer 0 0 0 0
Penile (penis)
Cancer 0 0 0 0
Testicular
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Abiraterone Acetate
Treatment: Drugs - Prednisone\Prednisolone

Treatment: Drugs: Abiraterone Acetate
Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets once daily.

Treatment: Drugs: Prednisone\Prednisolone
Participants will receive prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg (if prednisone is not available).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Confirmed prostate cancer
* Prostate cancer progression after previous chemotherapy as assessed by the investigator
* Received at least 1 but not more than 2 chemotherapy regimens for metastatic CRPC (at least one regimen must have contained a taxane such as docetaxel)
* Serum testosterone of less than 50ng/dL (less than 2.0 nM)
* Eastern Cooperative Oncology Group (ECOG) performance status of <=2 (ie, patients who do not have symptoms of prostate cancer and who are fully active, patients who have symptoms but are able to perform light work, or patients who are able to get around and are capable of taking care of themselves but are unable to carry out any work activities)
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Serious or uncontrolled co-existent non-malignant disease (including active and uncontrolled infection)
* Active or symptomatic viral hepatitis or chronic liver disease or any abnormal liver function assessed by liver function tests
* Clinically significant heart disease as assessed by the Investigator or uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg)
* History of gastrointestinal disorders that may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction
* Known brain metastasis (ie, spread of cancer to the brain)

Study design
Purpose of the study
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
APPROVED_FOR_MARKETING
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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- Adelaide
Recruitment hospital [2] 0 0
- Bedford Park
Recruitment hospital [3] 0 0
- Box Hill
Recruitment hospital [4] 0 0
- Camperdown
Recruitment hospital [5] 0 0
- Footscray
Recruitment hospital [6] 0 0
- Garran
Recruitment hospital [7] 0 0
- Geelong
Recruitment hospital [8] 0 0
- Heidelberg
Recruitment hospital [9] 0 0
- Herston
Recruitment hospital [10] 0 0
- Hobart
Recruitment hospital [11] 0 0
- Kogarah
Recruitment hospital [12] 0 0
- Kurralta Park
Recruitment hospital [13] 0 0
- Liverpool
Recruitment hospital [14] 0 0
- Nedlands
Recruitment hospital [15] 0 0
- Port Macquarie
Recruitment hospital [16] 0 0
- Randwick
Recruitment hospital [17] 0 0
- South Brisbane
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- Southport Qld
Recruitment hospital [19] 0 0
- Subiaco
Recruitment hospital [20] 0 0
- Sydney
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- Tamworth
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- Wahroonga
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- Westmead
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- Wodonga
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- Woolloongabba
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- Adelaide
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- Bedford Park
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- Box Hill
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- Camperdown
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- Footscray
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- Garran
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- Geelong
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- Heidelberg
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- Herston
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- Hobart
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- Kogarah
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- Kurralta Park
Recruitment postcode(s) [13] 0 0
- Liverpool
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- Nedlands
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- Port Macquarie
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- Randwick
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- South Brisbane
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- Southport Qld
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- Subiaco
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- Sydney
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- Tamworth
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- Wahroonga
Recruitment postcode(s) [23] 0 0
- Westmead
Recruitment postcode(s) [24] 0 0
- Wodonga
Recruitment postcode(s) [25] 0 0
- Woolloongabba
Recruitment outside Australia
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Omsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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Rostov-On-Don
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St Petersburg
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Stavropol
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Thailand
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Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01217697