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A QT/QTc and Multi-Dose Pharmacokinetic (PK) Study of Abiraterone Acetate - NCT00910754-14263(Clinical Trial 295911)



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City:  Buffalo
State:  
NY
Zip Code: 14263
Conditions: Metastatic Castration-Resistant Prostate Cancer
Purpose: This is a phase 1B study to determine the effect of abiraterone acetate and prednisone on the conduction of electricity in the heart and the blood levels of abiraterone acetate and abiraterone in the body over a period of time.
Study summary:
Criteria: Inclusion Criteria: - Metastatic castration resistant prostate cancer - No chemotherapy/biologic therapy or no more than 1 line of prior chemotherapy/biologic therapy - Progression after previous prostate cancer therapy - ECOG performance status of either 0 or 1 - Medical or surgical castration with testosterone of less than 50ng/dL - Able to provide informed consent Exclusion Criteria: - Prior chemotherapy with mitoxantrone or anthracyclines - Known brain metastasis - Clinically significant heart disease - Diagnosis of arrhythmia requiring therapy - Abnormal electrocardiogram Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria. Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: January 20, 2010
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