A QT/QTc and Multi-dose PK Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration- Resistant Prostate Cancer
This is an open-label (identity of assigned study drugs will be known) study to evaluate the
effects of abiraterone acetate plus prednisone on the conduction of electric charges within
the heart in male patients diagnosed with metastatic castration-resistant prostate cancer (a
progressive form of prostate cancer that spreads to other parts of the body). At various
time points outline in the protocol from Day -1 of Cycle 1 up to Day 2 of Cycle 2, patients
will have electrocardiograms extracted from a 24 hour holter-monitor to evaluate the
electrical activity of their heart. Efficacy will be assessed according to Prostate Cancer
Working Group 2 and modified Response Evaluation Criteria In Solid Tumors criteria. Serial
blood samples for pharmacokinetic analysis (how the drug concentrations change over time)
will be collected and safety will be monitored throughout the study. Patients will take 1000
mg of abiraterone acetate once daily plus prednisone 5 mg twice daily orally (by mouth)
until disease progression and will be followed up for up to 60 months.
Interventional
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mean maximal change in electrocardiogram QTc
Baseline on Day -1 of Cycle 1 compared with Day 1 of Cycle 1, Cycle 2, Cycle 4 and every third cycle thereafter
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR016942
NCT00910754
May 2009
May 2012
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Albany, New York 12208 | |
Austin, Texas 78705 | |
Charleston, South Carolina | |
Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
South Texas Accelerated Research Therapeutics | San Antonio, Texas 78229 |