Status:
COMPLETED
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer Who Have Received Docetaxel
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Prostate Cancer
Eligibility:
MALE
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) who have received docetaxel-based chemot...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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 been used at least 1 but not more than 2 cytotoxic chemotherapy regimens for Metastatic Castration-Resistant Prostate Cancer (mCRPC). At least 1 regimen must have contained docetaxel. If docetaxel-containing chemotherapy was used more than once, those of regimens containing docetaxel would be considered as 1 regimen in total
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01795703
Start Date
June 1 2012
End Date
October 1 2014
Last Update
November 4 2015
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Asahi, Japan
2
Fukuoka, Japan
3
Kanazawa, Japan
4
Kita-Gun, Japan