A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.
This is an open-label (all people know the identity of the intervention), multicenter,
single arm (only one treatment group) study to evaluate the efficacy and safety of
abiraterone acetate in patients with mCRPC. The study will be divided into screening phase
(up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of
treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled
into this study. Safety evaluations for adverse events, clinical laboratory tests,
electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug)
assessments will be conducted in this study. Patients will continue to receive abiraterone
acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
- Has documented Prostate Specific Antigen (PSA) progression according to
protocol-specific prostate specific antigen working group (PSAWG) eligibility
criteria
- Has undergone prior chemotherapy for prostate cancer with regimen(s) containing
Docetaxel
- Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
- Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior
to the treatment
- Eastern Cooperative Oncology Group Performance Status less than or equal to 2
Exclusion Criteria:
- Active or uncontrolled autoimmune disease that may require corticosteroid therapy
- Serious or uncontrolled co-existent non-malignant disease, including active and
uncontrolled infection
- Uncontrolled hypertension
- Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
- Has abnormal liver function tests
- Surgery or local prostatic intervention within 30 days of the first dose
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Prostate specific antigen (PSA) response rate
Outcome Description:
PSA response rate is defined as the number of patients achieving a PSA decline of at least 50% according to the Prostate-Specific Antigen Working Group (PSAWG) criteria.
Outcome Time Frame:
Day 1 of treatment Cycles until the date of first documented PSA progression, lost to follow Up or withdrawn consent, as assessed up to 9 months after the last patient is enrolled
Safety Issue:
No
Principal Investigator
Janssen Research & Development, LLC Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Janssen Research & Development, LLC
Authority:
Taiwan: Taiwan Food and Drug Administration
Study ID:
CR100009
NCT ID:
NCT01685983
Start Date:
August 2011
Completion Date:
January 2014
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- Metastatic-castration resistant prostate cancer
- Prostate specific antigen
- Abiraterone acetate
- JNJ-212082
- Abiraterone
- Prednisolone
- Androgen Deprivation
- Docetaxel-based chemotherapy
- Prostatic Neoplasms
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