A QT/QTc and Multi-Dose Pharmacokinetic (PK) Study of Abiraterone Acetate - NCT00910754-14263 (Clinical Trial 295911)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy295911.aspx
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| City: |
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Buffalo |
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State:
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NY |
| Zip Code: |
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14263 |
| Conditions: |
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Metastatic Castration-Resistant Prostate Cancer |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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. |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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January 20, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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