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An open-label study to investigate the cardiac safety profile of cabazitaxel in patients with advanced solid tumors

Bibliographic reference Maison-Blanche, Pierre ; Dakhil, Shaker ; Baron, Ari ; Rottey, Sylvie ; Millard, Fred ; et. al. An open-label study to investigate the cardiac safety profile of cabazitaxel in patients with advanced solid tumors. In: Cancer Chemotherapy and Pharmacology, Vol. 73, no.6, p. 1241-1252 (2014)
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  1. de Bono Johann Sebastian, Oudard Stephane, Ozguroglu Mustafa, Hansen Steinbjørn, Machiels Jean-Pascal, Kocak Ivo, Gravis Gwenaëlle, Bodrogi Istvan, Mackenzie Mary J, Shen Liji, Roessner Martin, Gupta Sunil, Sartor A Oliver, Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial, 10.1016/s0140-6736(10)61389-x
  2. Shah Rashmi R, Drugs, QT Interval Prolongation and ICH E14 : The Need to Get it Right, 10.2165/00002018-200528020-00003
  3. Rock Edwin P., Finkle John, Fingert Howard J., Booth Brian P., Garnett Christine E., Grant Stephen, Justice Robert L., Kovacs Richard J., Kowey Peter R., Rodriguez Ignacio, Sanhai Wendy R., Strnadova Colette, Targum Shari L., Tsong Yi, Uhl Kathleen, Stockbridge Norman, Assessing proarrhythmic potential of drugs when optimal studies are infeasible, 10.1016/j.ahj.2009.02.020
  4. Valentin Jean-Pierre, Reducing QT liability and proarrhythmic risk in drug discovery and development : Reducing QT liability and proarrhythmic risk, 10.1111/j.1476-5381.2009.00547.x
  5. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) (2005) Guidance for industry. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Available at: . Accessed 1 Apr 2014
  6. Nada Adel, Gintant Gary A., Kleiman Robert, Gutstein David E., Gottfridsson Christer, Michelson Eric L., Strnadova Colette, Killeen Matthew, Geiger Mary Jane, Fiszman Mónica L., Koplowitz Luana Pesco, Carlson Glenn F., Rodriguez Ignacio, Sager Philip T., The evaluation and management of drug effects on cardiac conduction (PR and QRS Intervals) in clinical development, 10.1016/j.ahj.2013.01.011
  7. Garnett Christine E., Zhu Hao, Malik Marek, Fossa Anthony A., Zhang Joanne, Badilini Fabio, Li Jianguo, Darpö Börje, Sager Philip, Rodriguez Ignacio, Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects, 10.1016/j.ahj.2012.02.023
  8. Newby L. Kristin, Rodriguez Ignacio, Finkle John, Becker Richard C., Hicks Karen A., Hausner Elizabeth, Chesler Ruth, Harper Courtney, Targum Shari, Berridge Brian R., Lewis Eric, Walker Dana B., Dollery Colin, Turner J. Rick, Krucoff Mitchell W., Troponin measurements during drug development—considerations for monitoring and management of potential cardiotoxicity, 10.1016/j.ahj.2011.04.005
  9. Sager Philip, Heilbraun Jeffrey, Turner J. Rick, Gintant Gary, Geiger Mary J., Kowey Peter R., Mansoor George A., Mendzelevski Boaz, Michelson Eric L., Stockbridge Norman, Weber Michael A., White William B., Assessment of drug-induced increases in blood pressure during drug development: Report from the Cardiac Safety Research Consortium, 10.1016/j.ahj.2013.01.002
  10. Morganroth J, Shah R R, Scott J W, Evaluation and Management of Cardiac Safety Using the Electrocardiogram in Oncology Clinical Trials: Focus on Cardiac Repolarization (QTc Interval), 10.1038/clpt.2009.214
  11. Sarapa Nenad, Britto Margaret R, Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents, 10.1517/14740338.7.3.305
  12. U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute (2010) Common terminology criteria for adverse events (CTCAE) Version 4.02. Available at: . Accessed 1 Apr 2014
  13. Mason Robert E., Likar Ivan, A new system of multiple-lead exercise electrocardiography, 10.1016/0002-8703(66)90182-7
  14. Kligfield P, Gettes LS, Bailey JJ, Childers R, Deal BJ, Hancock EW, van Herpen G, Kors JA, Macfarlane P, Mirvis DM, Pahlm O, Rautaharju P, Wagner GS, Josephson M, Mason JW, Okin P, Surawicz B, Wellens H (2007) Recommendations for the standardization and interpretation of the electrocardiogram: part I: the electrocardiogram and its technology: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society: endorsed by the International Society for Computerized Electrocardiology. Circulation 115:1306–1324
  15. Ferron Géraldine M., Dai Yang, Semiond Dorothée, Population pharmacokinetics of cabazitaxel in patients with advanced solid tumors, 10.1007/s00280-012-2058-9
  16. Mita A. C., Denis L. J., Rowinsky E. K., DeBono J. S., Goetz A. D., Ochoa L., Forouzesh B., Beeram M., Patnaik A., Molpus K., Semiond D., Besenval M., Tolcher A. W., Phase I and Pharmacokinetic Study of XRP6258 (RPR 116258A), a Novel Taxane, Administered as a 1-Hour Infusion Every 3 Weeks in Patients with Advanced Solid Tumors, 10.1158/1078-0432.ccr-08-0596
  17. Diéras V., Lortholary A., Laurence V., Delva R., Girre V., Livartowski A., Assadourian S., Semiond D., Pierga J.Y., Cabazitaxel in patients with advanced solid tumours: Results of a Phase I and pharmacokinetic study, 10.1016/j.ejca.2012.07.008
  18. Fingert Howard, Varterasian Mary, Safety biomarkers and the clinical development of oncology therapeutics: Considerations for cardiovascular safety and risk management, 10.1208/aapsj080110
  19. Recent Topics, 10.1016/s0033-0620(01)70019-9
  20. Ridoux Laurence, Semiond Dorothée, Vincent Carine, Fontaine Hélène, Mauriac Christine, Sanderink Gerard, Oprea Corina, Clive Sally, Abstract 749: A Phase I, open-label study investigating the disposition of [14C]-cabazitaxel in patients with advanced solid tumors, 10.1158/1538-7445.am2012-749
  21. Gonullu Guzin, Demircan Sabri, Demirag Mustafa Kemal, Erdem Dilek, Yucel Idris, Electrocardiographic findings of palonosetron in cancer patients, 10.1007/s00520-011-1226-5
  22. Doggrell Sheila A, Hancox Jules C, Cardiac safety concerns for ondansetron, an antiemetic commonly used for nausea linked to cancer treatment and following anaesthesia, 10.1517/14740338.2013.780026
  23. Pivot X., Koralewski P., Hidalgo J. L., Chan A., Goncalves A., Schwartsmann G., Assadourian S., Lotz J. P., A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients, 10.1093/annonc/mdn171
  24. Sanofi U.S.LLC (2010) JEVTANA® (cabazitaxel) injection, prescribing information. Bridgewater, NJ, USA, 2010. Available at: . Accessed 1 Apr 2014
  25. Barbey Jean T., Pezzullo John C., Soignet Steven L., Effect of Arsenic Trioxide on QT Interval in Patients With Advanced Malignancies, 10.1200/jco.2003.10.009
  26. Health Canada (2010) Guidance document. Guide for the analysis and review of QT/QTc interval data. Available at: . Accessed 1 Apr 2014