Overview

A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer

Status:
Completed
Trial end date:
2014-10-17
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to investigate safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Abiraterone Acetate
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
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)