Ontology type: schema:ScholarlyArticle Open Access: True
2012-08
AUTHORSA. W. Tolcher, K. N. Chi, N. D. Shore, R. Pili, A. Molina, M. Acharya, T. Kheoh, J. J. Jiao, M. Gonzalez, A. Trinh, C. Pankras, N. Tran
ABSTRACTPURPOSE: Abiraterone is the active metabolite of the pro-drug abiraterone acetate (AA) and a selective inhibitor of CYP17, a key enzyme in testosterone synthesis, and improves overall survival in postdocetaxel metastatic castration-resistant prostate cancer (mCRPC). This open-label, single-arm phase 1b study was conducted to assess the effect of AA and abiraterone on the QT interval. METHODS: The study was conducted in 33 patients with mCRPC. Patients received AA 1,000 mg orally once daily + prednisone 5 mg orally twice daily. Electrocardiograms (ECGs) were collected in triplicate using 12-lead Holter monitoring. Baseline ECGs were obtained on Cycle 1 Day-1. Serial ECG recordings and time-matched pharmacokinetic (PK) blood samples were collected over 24 h on Cycle 1 Day 1 and Cycle 2 Day 1. Serial PK blood samples were also collected over 24 h on Cycle 1 Day 8. RESULTS: After AA administration, the upper bound of the 2-sided 90 % confidence interval (CI) for the mean baseline-adjusted QTcF change was <10 ms; no patients discontinued due to QTc prolongation or adverse events. No apparent relationship between change in QTcF and abiraterone plasma concentrations was observed [estimated slope (90 % CI): 0.0031 (-0.0040, 0.0102)]. CONCLUSIONS: There is no significant effect of AA plus prednisone on the QT/QTc interval in patients with mCRPC. More... »
PAGES305-313
http://scigraph.springernature.com/pub.10.1007/s00280-012-1916-9
DOIhttp://dx.doi.org/10.1007/s00280-012-1916-9
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PUBMEDhttps://www.ncbi.nlm.nih.gov/pubmed/22752297
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