Overview

A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer

Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone acetate and oral prednisone following short-term administration after standardized low-fat or high-fat meals to patients with metastatic (spreading) castration-resistant prostate cancer (mCRPC).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Ortho Inc., Canada
Treatments:
Abiraterone Acetate
Prednisone
Criteria
Inclusion Criteria:

- Adenocarcinoma of the prostate

- Metastatic disease documented by bone, computed tomography (CT) or magnetic resonance
imaging (MRI) scan

- Surgical or medical castration with testosterone less than 50 ng/dL (< 2.0 nM)

- Prostate-specific antigen (PSA) or radiographic progression documented by assessments
specified in study protocol

- Platelets >100,000/µl

- Hemoglobin >=9.0 g/dL

- Liver function tests (LFTs): Serum bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN;
Eastern Cooperative Oncology Group (ECOG) status score of <=2

Exclusion Criteria:

- Small cell carcinoma of the prostate

- Known brain metastasis, chronic liver disease with elevated LFTs

- Prior cytotoxic chemotherapy for metastatic prostate cancer

- Treatment of prostate cancer within 30 days of Day 1 Cycle 1 with surgery, radiation,
chemotherapy or immunotherapy

- Use of investigational drug within 30 days of Day 1 Cycle 1 or current enrollment in
an investigational drug or device study

- Recent history of ischemic heart disease, Electrocardiogram (ECG) abnormalities or
atrial fibrillation

- Active infection or other medical condition that would make prednisone
(corticosteroid) use contraindicated

- Chronic medical condition requiring a higher dose of corticosteroid than prednisone 5
mg twice daily