Status:
COMPLETED
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
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Prostate Neoplasms
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a multicenter, open-label study of 24 (up to a total of 28) men to assess the short-term safety of oral abiraterone acetate 1 g and oral prednisone 5 mg twice daily administered in the modifie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01424930
Start Date
October 1 2011
End Date
May 1 2013
Last Update
July 25 2014
Active Locations (2)
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1
Edmonton, Alberta, Canada
2
Vancouver, British Columbia, Canada