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Dr. Michelle Rudek-Renaut

Ph.D., Pharm.D.
Research Summary

Dr. Rudek is investigating the pharmacokinetic and pharmacodynamic behavior of anticncer gents and identify determinants that impact on the PK/PD variability of these agents with the hopes of individualizing therapy.

Journal Citations

Rudek MA, Figg WD, Dyer V, Dahut W, Turner ML, Steinberg SM, Liewehr DJ, Kohler DR, Pluda JM, Reed E. A phase I clinical trial of oral COL-3, a matrix metalloproteinase inhibitor, in patients with refractory metastatic cancer. J Clin Oncol 2001;19(2):584-592.

Cianfrocca M, Cooley TP, Lee JY, Rudek MA, Scadden DT, Ratner L, Pluda JM, Figg WD, Krown SE, Dezube BJ. Matrix metalloproteinase inhibitor COL-3 in the treatment of AIDS-related Kaposi's sarcoma: a phase I AIDS malignancy consortium study. J Clin Oncol 2002;20(1):153-159.

Rudek MA, Venitz J, Ando Y, Reed E, Pluda JM, Figg WD. Factors involved in the pharmacokinetics of COL-3, a matrix metalloproteinase inhibitor in patients with refractory metastatic cancer: clinical and experimental studies. J Clin Pharmacol 2003;43(10):1124-1135.

Rudek MA, Bauer KS Jr., Lush RM 3rd, Stinson SF, Senderowicz AM, Headlee DJ, Arbuck SG, Cox MC, Murgo AJ, Sausville EA, Figg WD. Clinical pharmacology of flavopiridol following a 72-hour continuous infusion. Ann Pharmacother 2003;37(10): 1369-1374.

Rudek MA, Sparreboom A, Garrett-Mayer ES, Armstrong DK, Wolff AC, Verweij J, Baker SD. Factors affecting pharmacokinetic variability following doxorubicin and docetaxel-based therapy. Eur J Cancer. 2004;40(8):1170-1178.

Rudek MA, Zhao M, He P, Hartke C, Gilbert J, Gore SD, Carducci MA, Baker SD. Pharmacokinetics of 5- azacytidine given with phenylbutyrate in patients with refractory solid tumors or hematologic malignancies. J Clin Oncol 2005;23(17):3906-3911.

Dees EC, Baker SD, O'Reilly S, Rudek MA, Davidson SB, Aylesworth C, Elza-Brown K, Carducci MA, Donehower RC. A phase I and pharmacokinetic study of short infusions of UCN-01 in patients with refractory solid tumors. Clin Cancer Res 2005;11(2 Pt 1):664-671.

Rudek MA, Zhao M, Smith NF, Robey RW, He P, Hallur G, Khan S, Hidalgo M, Jimeno A, Colevas AD, Messersmith WA, Wolff AC, Baker SD. In vitro and in vivo metabolism of dimethyl benzoylphenyl urea (BPU), a novel oral tubulin-interactive agent. Clin Cancer Res 2005;11(23):8503-8511.

Gore SD, Baylin S, Sugar E, Carraway H, Miller CB, Carducci M, Grever M, Galm O, Dauses T, Karp JE, Rudek MA, Zhao M, Smith BD, Manning J, Jiemjit A, Dover G, Mays A, Zweibel J, Murgo A, Weng L, Herman J. Combined DNA methyltransferase and histone deacetylase inhibition in the treatment of myeloid neoplasms. Cancer Res 2006;66(12):6361-6369.

Messersmith WA, Rudek MA, Baker SD, Zhao M, Collins C, Colevas AD, Donehower RC, Carducci MA, Wolff AC. Phase I study of continuous weekly dosing of dimethyl benzoylphenylurea (BPU) in patients with solid tumors. Eur J Cancer, 2007;43(1):78-86.

Jimeno A, Rudek MA, Purcell WT, Laheru D, Messersmith WA, Dancey J, Carducci MA, Baker SD, Hidalgo M, Donehower RC. Phase I and pharmacokinetic study of UCN-01 in combination with irinotecan in patients with solid tumors. Cancer Chemother Pharmacol, 2008;61(3):423-433.

Jimeno A, Rudek MA, Kulesza P, Ma WW, Wheelhouse J, Howard A, Khan Y, Zhao M, Jacene H, Messersmith WA, Laheru D, Donehower RC, Garrett-Mayer E, Baker SD, Hidalgo M. Pharmacodynamic-guided modified continuous reassessment method-based, dose-finding study of rapamycin in adult patients with solid tumors. J Clin Oncol. 2008;26(25):4172-4179.

Jimeno A, Li J, Messersmith WA, Laheru D, Rudek MA, Maniar M, Hidalgo M, Baker SD, Donehower RC. Phase I study of ON 01910.Na, a novel modulator of the Polo-Like Kinase 1 pathway, in adult patients with solid tumors. J Clin Oncol. 2008;26(34):5504-5510.

Bisht S, Feldmann G, Koorstra JBM, Mullendore M, Alvarez H, Karikari C, Rudek MA, Lee CK, Maitra A, Maitra A. An orally bioavailable polymeric nanoparticle formulation of rapamycin (Nanorapamycin) for systemic cancer therapy. Mol Cancer Ther. 2008;7(12):3878-88.

Tsimberidou AM, Rudek MA, Hong D, Ng CS, Blair J, Goldsweig H, Kurzrock R. Phase 1 first-in-human, clinical study of S- trans,trans-farnesylthiosalicylic acid (salirasib) in patients with solid tumors. Cancer Chemother Pharmacol. 2010;65(2):235-241.

Lin J, Gilbert J, Rudek MA, Zweibel J, Jiemjit A, Zhao M, Donehower RC, Herman J, Ambinder R, Gore S, Baker SD, Carducci MA. A phase I dose-finding study of 5-azacytidine in combination with phenylbutyrate in patients with refractory solid tumors. Clin Cancer Res. 2009;15(19):6241-6249.

Pratz KW, Cho E, Levis MJ, Karp JE, Gore SD, McDevitt M, Stine A, Zhao M, Baker SD, Carducci MA, Wright JJ, Rudek MA, Smith BD. A pharmacodynamic study of sorafenib in patients with relapsed and refractory acute leukemias. Leukemia. 2010 Jun 10. [Epub ahead of print]

Altiok, S.; Mezzadra, H.; Jagannath, S.; Tsottles, N.; Rudek, M.A.; Abdallah, N.; Berman, D.; Forastiere, A.; Gibson, M.K. A novel pharmacodynamic approach to assess and predict tumor response to the epidermal growth factor receptor inhibitor gefitinib in patients with esophageal cancer. Int J Oncol. 2010 Jan;36(1):19-27.

Armstrong, A.J.; Netto, G.J.; Rudek, M.A.; Halabi, S.; Wood, D.P.; Creel, P.A.; Mundy, K.; Davis, S.L.; Wang, T.; Albadine, R.; Schultz, L.; Partin, A.W.; Jimeno, A.; Fedor, H.; Febbo, P.G.; George, D.J.; Gurganus, R.; De Marzo, A.M.; Carducci, M.A. A pharmacodynamic study of rapamycin in men with intermediate- to high-risk localized prostate cancer. Clin Cancer Res. 2010 Jun 1;16(11):3057-3066.

Bisht, S.; Mizuma, M.; Feldmann, G.; Ottenhof, N.A.; Hong, S.M.; Pramanik, D.; Chenna, V.; Karikari, C.; Sharma, R.; Goggins, M.G.; Rudek, M.A.; Ravi, R.; Maitra, A. Systemic administration of polymeric nanoparticle-encapsulated curcumin (NanoCurc) blocks tumor growth and metastases in preclinical models of pancreatic cancer. Mol Cancer Ther. 2010 Aug;9(8):2255-2264.

Franke, R.M.; Carducci, M.A.; Rudek, M.A.; Baker, S.D.; Sparreboom, A. Castration-dependent pharmacokinetics of docetaxel in patients with prostate cancer. J Clin Oncol. 2010 Oct 20;28(30):4562-4567.

Garrido-Laguna, I.; Tan, A.C.; Uson, M.; Angenendt, M.; Ma, W.W.; Villaroel, M.C.; Zhao, M.; Rajeshkumar, N.V.; Jimeno, A.; Donehower, R.; Iacobuzio-Donahue, C.; Barrett, M.; Rudek, M.A.; Rubio-Viqueira, B.; Laheru, D.; Hidalgo, M. Integrated preclinical and clinical development of mTOR inhibitors in pancreatic cancer. Br J Cancer. 2010 Aug 24;103(5):649-655.

Hammers, H.J.; Verheul, H.M.; Salumbides, B.; Sharma, R.; Rudek, M.; Jaspers, J.; Shah, P.; Ellis, L.; Shen, L.; Paesante, S.; Dykema, K.; Furge, K.; Teh, B.T.; Netto, G.; Pili, R. Reversible epithelial to mesenchymal transition and acquired resistance to sunitinib in patients with renal cell carcinoma: evidence from a xenograft study. Mol Cancer Ther. 2010 Jun;9(6):1525-1535.

Li, L.; Zhao, M.; Navid, F.; Pratz, K.; Smith, B.D.; Rudek, M.A.; Baker, S.D. Quantitation of sorafenib and its active metabolite sorafenib N-oxide in human plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2010 Nov 1;878(29):3033-3038.

Ma, W.W.; Herman, J.M.; Jimeno, A.; Laheru, D.; Messersmith, W.A.; Wolfgang, C.L.; Cameron, J.L.; Pawlik, T.M.; Donehower, R.C.; Rudek, M.A.; Hidalgo, M. A tolerability and pharmacokinetic study of adjuvant erlotinib and capecitabine with concurrent radiation in resected pancreatic cancer. Transl Oncol. 2010;3(6):373-379.

Messersmith, W.A.; Jimeno, A.; Jacene, H.; Zhao, M.; Kulesza, P.; Laheru, D.A.; Kahn, Y.; Spira, A.; Dancey, J.; Iacobuzio-Donahue, C.; Donehower, R.C.; Carducci, M.; Rudek, M.A.; Hidalgo, M. Phase I trial of oxaliplatin, infusional 5-fluorouracil, and leucovorin (FOLFOX4) with erlotinib and bevacizumab in colorectal cancer. Clin Colorectal Cancer. 2010 Dec;9(5):297-304.

Pratz, K.W.; Cho, E.; Levis, M.J.; Karp, J.E.; Gore, S.D.; McDevitt, M.; Stine, A.; Zhao, M.; Baker, S.D.; Carducci, M.A.; Wright, J.J.; Rudek, M.A.; Smith, B.D. A pharmacodynamic study of sorafenib in patients with relapsed and refractory acute leukemias. Leukemia. 2010 Aug;24(8):1437-1444.

Reinhardt, S.; Zhao, M.; Mnatsakanyan, A.; Xu, L.; Ricklis, R.M.; Chen, A.; Karp, J.E.; Rudek, M.A. A rapid and sensitive method for determination of veliparib (ABT-888), in human plasma, bone marrow cells and supernatant by using LC/MS/MS. J Pharm Biomed Anal. 2010 May 1;52(1):122-128.

Sun, W.; Liu, Y.; Glazer, C.A.; Shao, C.; Bhan, S.; Demokan, S.; Zhao, M.; Rudek, M.A.; Ha, P.K.; Califano, J.A. TKTL1 is activated by promoter hypomethylation and contributes to head and neck squamous cell carcinoma carcinogenesis through increased aerobic glycolysis and HIF1alpha stabilization. Clin Cancer Res. 2010 Feb 1;16(3):857-866.

Weekes, C.D.; Nallapareddy, S.; Rudek, M.A.; Norris-Kirby, A.; Laheru, D.; Jimeno, A.; Donehower, R.C.; Murphy, K.M.; Hidalgo, M.; Baker, S.D.; Messersmith, W.A. Thymidylate synthase (TYMS) enhancer region genotype-directed phase II trial of oral capecitabine for 2nd line treatment of advanced pancreatic cancer. Invest New Drugs. 2010 Mar 23.

Cianfrocca, M.; Lee, S.; Von Roenn, J.; Rudek, M.A.; Dezube, B.J.; Krown, S.E.; Sparano, J.A. Pilot study evaluating the interaction between paclitaxel and protease inhibitors in patients with human immunodeficiency virus-associated Kaposi's sarcoma: an Eastern Cooperative Oncology Group (ECOG) and AIDS Malignancy Consortium (AMC) trial. Cancer Chemother Pharmacol. 2011 Jan 5.

Karp, J.E.; Smith, B.D.; Resar, L.S.; Greer, J.M.; Blackford, A.; Zhao, M.; Moton-Nelson, D.; Alino, K.; Levis, M.J.; Gore, S.D.; Joseph, B.; Carraway, H.; McDevitt, M.A.; Bagain, L.; Mackey, K.; Briel, J.; Doyle, L.A.; Wright, J.J.; Rudek, M.A. Phase I and pharmacokinetic study of bolus-infusion flavopiridol followed by cytosine arabinoside and mitoxantrone for acute leukemias. Blood. 2011 Jan 14;Epub 1/18/11.

Smith, B.D.; Jones, R.J.; Cho, E.; Kowalski, J.; Karp, J.E.; Gore, S.D.; Vala, M.; Meade, B.; Baker, S.D.; Zhao, M.; Piantadosi, S.; Zhang, Z.; Blumenthal, G.; Warlick, E.D.; Brodsky, R.A.; Murgo, A.; Rudek, M.A.; Matsui, W.H. Differentiation therapy in poor risk myeloid malignancies: Results of a dose finding study of the combination bryostatin-1 and GM-CSF. Leuk Res. 2011 Jan;35(1):87-94.


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