«Anastasia Ivanova, Ph.D. 1 4/1/2014 Anastasia Ivanova Department of Biostatistics University of North Carolina at Chapel Hill 3103-C ...»
60. Sanoff H.K., Davies J., Walko, C., Buie L., Chiu, W.K., Ivanova A., O'Neil, B., Stinchcombe, T.E., Keller, K., Dees, E.C. (2011). A Phase I trial of Vinflunine and Premetrexed in refractory solid tumors. Investigational New Drugs 29(1):131-136.
61. Sanoff H.K., Davies J., Walko, C., Irvin, W., Buie L., Keller, K., Ivanova A., Chiu, W.K., O'Neil, B., Stinchcombe, T.E., Dees, E.C. (2011). A phase I evaluation of the combination of vinflunine and erlotinib in patients with refractory solid tumors.
Investigational New Drugs 29(5):978-83. PMID: 20387090
62. Irvin, W.J., Orlowski, R.Z., Chiu, M., Carey, L.A., Collichio, F.A., Perou, C., Ivanova, A., Dees, E.C. (2010). Phase II Study of Bortezomib and Pegylated Liposomal Doxorubicin in the Treatment of Metastatic Breast Cancer. Clinical Breast Cancer 10(6):465-70.PMID: 21147690
63. O’Neil, B.H., Raftery, L., Calvo, B.F., Chakravarthy, B.H., Ivanova, A., Myers, M.O., Kim, H.J., Chan, E., Wise, P.E., Caskey, L.S., Bernard, S.A., Sanoff, H.K., Goldberg, R.M., Tepper, J.E. (2010). A phase I Study of Bortezomib in Combination with Standard 5-fluorouracil and External Beam Radiotherapy for the Treatment of Locally Advanced
or Metastatic Rectal Cancer. Clinical Colorectal Cancer, 9, 2, 119-125. PMID:
64. Singh, S.S., Mehedint, D.C., Ford, O.H., Jeyaraj, D.A., Pop, E.A., Maygarden, S.J., Ivanova, A., Chandrasekhar, R., Wilding, G.E., Mohler, JL. (2009). Comparison of ACINUS, Caspase-3 and TUNEL as Apoptotic Markers in Determination of Tumor Growth Rates of Clinically Localized Prostate Cancer using Image Analysis. The Prostate, 69, 1603-1610.
65. Knovich, M.A., Il'yasova, D., Ivanova, A., Molnar, I. (2008). The Association between Serum Copper and Anemia in the Adult NHANES II Population. British Journal of Nutrition, 99, 1226-1229. PMID: 18533287
66. Il’asova, D., Ivanova, A., Morrow, J.D., Cesari, M., Pahor, M. (2008). Correlation between two markers of inflammation, serum C-reactive protein (CRP) and interleukin-6 (IL-6) and indices of oxidative stress in patients with high risk of cardiovascular disease.
Anastasia Ivanova, Ph.D. 7 4/1/2014 Biomarkers 13, 41-51. PMID: 17852073
67. Dees, E.D., O’Neil, B.H., Lindley, C.M., Collichio, F., Carey, L.A., Collins, J., Riordan, W.J., Ivanova, A, Esseltine, D., Orlowski, R.Z. (2008). A Phase I and Pharmacologic Study of the Combination of Bortezomib and Pegylated Liposomal Doxorubicin in Patients with Refractory Solid Tumors. Cancer Chemotherapy and Pharmacology, 63, 99-107. PMID: 18327587
68. Wlassoff, W.A., Sivashinski, M.S., Ivanova, A., Appelbaum, J.G., Salganik, R.I. (2007).
Hydrogen peroxide overproduced in breast cancer cells can serve as anticancer prodrug stimulating hydroxyl radicals produced apoptosis under the effect of tamoxifen-ferrocene conjugate. Journal of Pharmacy and Pharmacology 59, 1549-1553.
69. Stinchcombe, T.E., Socinski, M.A., Walko, C.M., O’Neil, B.H., Collichio, F.A., Ivanova, A., Mu, H., Hawkins, M.J., Goldberg, R.M., Lindley, C., Dees, E.C.. (2007).
Phase I and Pharmacokinetic Trial of Carboplatin and Albumin-bound Paclitaxel, ABIAbraxane®) on Three Treatment Schedules in Patients with Solid Tumors. Cancer Chemotherapy and Pharmacology, 60 759-766.
70. Kelly, H., Kimmick, G., Dees, E.C., Collichio, F., Gatti, L., Sawyer, L., Ivanova, A., Dressler, L., Graham, M.L., Carey, L.A.. (2006). Response and cardiac toxicity of trastuzumab given in conjunction with weekly paclitaxel after doxorubicin/cyclophosphamide. Clinical Breast Cancer 7(3): 237-243.
71. Schroeder, J.C., Bensen, J.T., Su, J., Mishel, M., Ivanova, A., Smith, G., Godley, P., Fontham, E., Mohler, J.L.. (2006). The North Carolina-Louisiana Prostate Cancer Project (PCaP): Methods and design of a multidisciplinary population-based cohort study of racial differences in prostate cancer outcomes. The Prostate, 66, 11, 1162-1176.
72. Carson S.S., Kress, J.P., Rodgers, J.O., Vinayak, A., Campbell-Bright, S., Levitt, J., Bourdet, S., Ivanova, A., Henderson, A.G., Pohlman, A., Chang, L., Rich, P.B., Hall, J.
(2006). A randomized trial of intermittent lorazepam versus propofol with daily interruption in mechanically ventilated patients. Critical Care Medicine, 34, 1326-1332.
73. Socinski, M.A., Ivanova, A., Bakri, K., Wall, J., Baggstrom, M.Q., Hensing. T.A., Meras, A., Tynan, M., Beaumont, J., Peterman, A.H., Niell, H.B. (2006). A randomized phase II trial comparing every-3-week carboplatin/paclitaxel with every-3-week carboplatin and weekly paclitaxel in advanced non-small cell lung cancer, Annals of Oncology, 17, 104-109.
74. Konrad, T.R., Howard, D.L., Edwards, L., Ivanova, A., Carey, T. (2005). Physicianpatient racial concordance, continuity, and patterns of care for hypertension. American Journal of Public Health, 95, 2186-2190.
75. Orlowski, R.Z., Voorhees, P.M., Garcia, R.A., Hall, M.D., Kudrik, F.J., Allred, T., Johri, A.R., Jones, P.E., Ivanova, A., Van Deventer, H.W., Gabriel, D.A., Shea, T.C., Mitchell, B.S., Adams, J., Esseltine, D., Trehu, E.G., Green, M., Lehman, M.J., Natoli, S., Collins, J.M., Lindley, C.M., Dees, E.C. (2005). Phase I Trial of the Proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with advanced hematologic malignancies, Blood, 105, 3058 - 3065.
76. Il'yasova D., Morrow J.D., Ivanova A., Wagenknecht L.E. (2004). Epidemiological marker for oxidant status: comparison of the ELISA and the gas hromatography/mass spectrometry assay for urine 3-dinor-5,6-dihydro-15-F2t-isoprostane. Annals of Anastasia Ivanova, Ph.D. 8 4/1/2014 Epidemiology, 14(10), 793-797.
77. Peck, M.D., Kessler, M., Cairns, B.A., Chang, Y.H., Ivanova, A., Schooler, W. (2004).
Early enteral nutrition does not decrease hypermetabolism associated with burn injury.
Journal of Trauma, 57(6), 1143-1149.
78. Schwartz G, Il'yasova D, Ivanova A. (2003). Urinary cadmium, impaired fasting glucose, and diabetes in the NHANES III. Diabetes Care, 26 (2), 468-470.
79. Melki, S.A., Safar, A., Martin, J., Ivanova, A., Adi, M. (1999). Potential acuity pinhole:
A simple method to measure potential visual acuity in patients with cataracts, comparison to PAM. Ophthalmology, 106, 7-14.
Peer-Reviewed Book Chapters
80. Ivanova, A., Oron, A. (2013). Up-and-down and escalation designs. In Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials and Design, Hoboken: John Wiley & Sons, Inc.
81. Ivanova, A. (2008). Escalation and up-and-down designs. In Encyclopedia of Clinical Trials, Hoboken: John Wiley & Sons, Inc.
82. Ivanova, A. (2008). Phase I trials in oncology. In Encyclopedia of Clinical Trials, Hoboken: John Wiley & Sons, Inc.
83. Ivanova, A., Flournoy, N. (2008). Phase I clinical trials. Chapter 1 in Statistical Advances in the Biomedical Sciences: Clinical Trials, Epidemiology, Survival Analysis, and Bioinformatics (A. Biswas, S. Datta, J. Fine, M.Segal eds.). John Wiley, 3-15.
84. Kuznetsova, O., Ivanova, A. (2007). Allocation in randomized clinical trials. Chapter 8 in Pharmaceutical Statistics using SAS (C., D’Agostino, R., Dmitrienko, A., eds), SAS Publishing, pp 213 - 235.
85. Ivanova, A. (2006). Dose-finding in oncology - non-parametric methods. Chapter 4 in Dose Finding in Drug Development (N. Ting, ed.). Springer-Verlag, 49-58.
Non Peer-Reviewed Publications
Ivanova, A., Tamura, R. (2013). Letter to the Editor. Journal of Biopharmaceutical Statistics, 23, 709-710 Ivanova, A., Bunce, L. (2010). Design of Phase I trials. Chapter 11 in Fundamentals of Oncology Clinical Trials (K. Kelly, S. Halabi eds.). Demos Medical Publishing.
Ivanova, A., Flournoy, N. (2006). Up-and-down designs in toxicity studies. Chapter 11 in Statistical Methods for Dose-Finding Experiments (S. Chevret, ed.). John Wiley, 115-130.
Hu, F., Ivanova, A. (2004). Adaptive design. In Encyclopedia of Biopharmaceutical Statistics, 2nd edition, Marcel Dekker.
Ivanova, A. (2002). On phase I trials design: Letter to the editor. Controlled Clinical Trials, 23, 182-183.
Berger, V.W., Ivanova, A. (2001). Permutation tests for phase III clinical trials. Chapter 14 in S−PLUS in the Pharmaceutical Industry (Millard, S. Kruase, A., eds.), Springer-Verlag, 349-375.
Anastasia Ivanova, Ph.D. 9 4/1/2014 Manuscripts under review at a refereed journal Farnan, L., Ivanova, A., Peddada, S. Performance of the pool adjacent violators algorithm (PAVA) for correlated normally distributed. Submitted Song, G., Ivanova, A. Bayesian enrollment and stopping rules for managing toxicity requiring long follow-up in Phase II oncology trials. Submitted Song, G., Ivanova, A. Frequentist enrollment and stopping rules for managing toxicity requiring long follow-up in Phase II oncology trials. Submitted Ivanova, A., Deal, A. Two-stage design for phase II oncology trials with relaxed futility stopping. Submitted Barry, E.L., Mott, L.A., Rees, J.R., Melamed, M.L., Ivanova, A., Sandler, R.S., Ahnen, D.J., Bresalier, R.S., Summers, R.W., Bostick, R.M., Baron, J.A. Calcium supplementation increases blood creatinine levels in a randomized controlled trial. Submitted Chung, Y., Ivanova, A., Hudgens, M., Fine, J. Partial likelihood estimation of isotonic proportional hazards models. Submitted Hoberman, S., Ivanova, A. The properties of entropy as a measure of randomness in a clinical trial. Submitted Wang, Y., Ivanova, A. Dose-finding with continuous outcome in Phase I oncology trials.
Submitted Weir, M., Ivanova, A. et al. Safety Events in Kidney Transplant Recipients: Results from the Folic Acid for Vascular Outcome Reduction in Transplant (FAVORIT) Trial. Submitted Articles in Russian Ivanova, A. (1992). Stochastic stability of algorithms with discrete time. In The Monte Carlo Methods in Computational Mathematics, 66-70. (In Russian) Ivanova, A. (1991). Stochastic stability of algorithms when solving partial differential equations with the Monte Carlo method. Publications of St. Petersburg State University. (In Russian) Ivanova, A., Sushkov, Y.A. (1990). Multi-state systems with binary-polar functional elements.
Computational Cybernetics, 25, 38-42. (In Russian) Software http://cancer.unc.edu/biostatistics/program/ivanova/ Easy to use software for Phase II oncology trials, including continuous boundary for toxicity monitoring, Simon’s and Fleming’s two-stage designs, two-stage design with relaxed stopping for futility and two-stage design for ordinal outcomes.
Invited Presentations (presented or coauthored) Ivanova, A. Innovative dose-finding methods for Phase I oncology trials. FDA, Oncology, Silver Spring, MD, September 2013.
Dragalin, V., Ivanova, A. Enrichment Strategies in Adaptive Clinical Trials: Theory and Implementation. Short course, 2013 FDA/Industry Workshop. Washington DC, September 2013.
Anastasia Ivanova, Ph.D. 10 4/1/2014 Ivanova, A. Sample size considerations for the sequential parallel comparisons design. 2013 FDA/Industry Workshop. Washington DC, September 2013.
Ivanova, A. Treatment selection with the sequential parallel comparison design. Fourth International Workshop in Sequential Methodologies. Athens GA, July 2013.
Ivanova, A. Adaptive dose-finding: from audiometry to sleep apnea. ICSA/ ISBS joint statistical conference. Bethesda MD, June 2013.
Ivanova, A. Designs for trials with high placebo response. Society for Clinical Trials meeting.
Boston MA, May 2013.
Ivanova, A. Designs for trials with high placebo response. Department of Biostatistics, Johns Hopkins University. Baltimore MD, April 2013.
Ivanova, A. Adaptive two-stage trials with multiple treatment arms. COMPASS Consortium meeting. Philadelphia PA, April 2013.
Ivanova, A. Comparing strategies for trials with high placebo response. ENAR. Orlando FL, March 2013.
Ivanova, A. Learning with a two-stage design with multiple arms: adaptive and manageable.
DIA/Industry Workshop. Bethesda MD, October 2012.
Ivanova, A. High placebo response, crossover, placebo lead-in and randomized discontinuation designs. NC TraCS Biostatistics Seminar Series for Clinical and Translational Science Investigators. UNC September 2012.
Ivanova, A. Comparing designs for trials with high placebo response 2012 FDA/Industry Workshop. Washington DC, September 2012.
Ivanova, A., Miller, E., Gallo, P. Recent Adaptive Designs in Phase 2 and Phase 3: Theory and Implementation Short course, 2012 FDA/Industry Workshop. Washington DC, September 2012.
Ivanova, A. Comparing Strategies for Trials with High Placebo Response. Biopharmaceutical Section Web-based Training Series, August 2012.
Ivanova, A. Sample size re-estimation in Phase III trials. Quintiles, Durham NC, July 2012.
Ivanova, A. Beyond the 3+3 design: methods for Phase I and II oncology trials. Quintiles, Durham NC, May 2012.
Tamura, R., Ivanova, A. A doubly enriched clinical trial design merging placebo lead-in and randomized withdrawal, ENAR, Washington DC April 2012.
Ivanova, A. Adaptive Two-Stage Designs for Multi-Arm Trials. BASS XVIII, Savannah GA, November 2011.
Ivanova, A. Adaptive dose-finding in first-in-man: case study. 2011 FDA/Industry Workshop.
Washington DC, September 2011.
Ivanova, A. Beyond the 3+3 design: novel methods for oncology trials. University of Alabama Comprehensive Cancer Center, Birmingham AL, June 2011.
Ivanova, A. Adaptive designs for dose-finding trials. Duke University, December 17, 2010.
Ivanova, A. Can we use the CRM in Phase 2 trials? GlaxoSmithKline, October 2010.
Ivanova, A. The CRM: pros, cons and misconceptions. FDA, Oncolgoy, Silver Spring, MD, September 2010.
Ivanova, A. Lymph node identification study: can we do better with optimal design? MODA9, Bertrino, Italy, June 2010.
Ivanova, A. Adaptive Dose Finding. The 4th Annual Probability and Statistics Day. UMBC, Anastasia Ivanova, Ph.D. 11 4/1/2014 Baltimore, MD April 24, 2010.
Ivanova, A. Dose finding in phase 2 trials. UK Medical Research Council Workshop on DoseFinding Methodology in Early Phase Clinical Trials. Reading, UK, March 2010.
Ivanova, A. Innovative dose finding designs. 60th anniversary of the Department of Biostatistics, UNC Chapel Hill. Chapel Hill NC, October 2009.