A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration Resistant Prostate Cancer Patients Who Are Chemotherapy-Naïve
20 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration Resistant Prostate Cancer Patients Who Are Chemotherapy-Naïve
This is a multi-center (conducted in more than one center), open-label (all people know the
identity of the intervention), single-arm study to investigate safety and efficacy of
abiraterone. The study consists of 3 phases: Screening phase (consists of 14 days before
study commences on Day -1); Treatment phase (consists of 28-daily dosing cycles wherein
abiraterone 1000 milligram [mg] once daily along with 5 mg prednisolone twice daily will be
given until disease progression or unacceptable toxicity is observed); and Follow-up phase
(up to 5 years or until survival after the first dose of study drug). Abiraterone will be
orally administered daily as at least 1 hour before the meal or 2 hours after the meal. Dose
reduction will be allowed at the Investigator's discretion but not lower than 500 mg per
day. Participants will discontinue study treatment at disease progression unless, in the
Investigator's opinion, it is deemed that the participants will continue to derive benefit
from abiraterone. Efficacy will be evaluated primarily through decline in prostate-specific
antigen (substance in blood that is measured to check for prostate cancer) after 12 weeks of
therapy. Participants' safety will be monitored throughout the study.
Inclusion Criteria:
- In-patients or out-patients with histologically or cytologically confirmed
adenocarcinoma of the prostate without neuroendocrine differentiation or small cell
histology
- Have surgically or medically castrated, with testosterone levels of less than 50
nanogram per deciliter
- Have prostate-specific antigen (PSA) level of at least 5 nanogram per milliliter
- Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG)
eligibility criteria or objective progression by Response Evaluation Criteria in
Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease
after androgen deprivation
- Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
Exclusion Criteria:
- Has received other hormonal therapy, including any dose of finasteride, dutasteride,
any herbal product known to decrease PSA levels or any systemic corticosteroid within
4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer
- Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy
(including provenge) within 4 weeks, or single fraction of palliative radiotherapy
within 2 weeks prior to Cycle 1 Day 1
- Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day
1. In addition, any clinically relevant sequel from the surgery must have resolved
prior to Cycle 1 Day 1
- Has clinically significant heart disease as evidenced by myocardial infarction, or
arterial thrombotic events, severe or unstable angina, or New York Heart Association
(NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less
than 50 percent within 6 months prior to Cycle 1 Day 1
- Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160
millimeter of mercury or diastolic blood pressure greater than or equal to 95
millimeter of mercury)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of participants achieving Prostate-Specific Antigen (PSA) response up to 12 weeks
Outcome Description:
The PSA response will be evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline up to 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.
Outcome Time Frame:
Baseline up to 12 weeks
Safety Issue:
No
Principal Investigator
Janssen Research & Development, LLC Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Janssen Research & Development, LLC
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
CR017059
NCT ID:
NCT01756638
Start Date:
June 2012
Completion Date:
September 2014
Related Keywords:
- Prostate Cancer
- Prostate cancer
- Abiraterone acetate
- JNJ-212082
- Prostatic Neoplasms
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