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Cancer clinical investigators should converge with pharmacometricians.

Maitland ML, O'Cearbhaill RE, Gobburu J.

Clin Cancer Res. 2019 Jun 27. pii: clincanres.1067.2019. doi: 10.1158/1078-0432.CCR-19-1067. [Epub ahead of print]


Comparison of tumor size assessments in tumor growth inhibition-overall survival models with second-line colorectal cancer data from the VELOUR study.

Claret L, Pentafragka C, Karovic S, Zhao B, Schwartz LH, Maitland ML, Bruno R.

Cancer Chemother Pharmacol. 2018 Jul;82(1):49-54. doi: 10.1007/s00280-018-3587-7. Epub 2018 Apr 26.


Clinical pharmacodynamic/exposure characterisation of the multikinase inhibitor ilorasertib (ABT-348) in a phase 1 dose-escalation trial.

Maitland ML, Piha-Paul S, Falchook G, Kurzrock R, Nguyen L, Janisch L, Karovic S, McKee M, Hoening E, Wong S, Munasinghe W, Palma J, Donawho C, Lian GK, Ansell P, Ratain MJ, Hong D.

Br J Cancer. 2018 Apr;118(8):1042-1050. doi: 10.1038/s41416-018-0020-2. Epub 2018 Mar 19.


PharmGKB summary: sorafenib pathways.

Gong L, Giacomini MM, Giacomini C, Maitland ML, Altman RB, Klein TE.

Pharmacogenet Genomics. 2017 Jun;27(6):240-246. doi: 10.1097/FPC.0000000000000279. Review. No abstract available.


A Pharmacokinetic and Safety Study of Trebananib, an Fc-Fusion Peptibody, in Patients With Advanced Solid Tumors and Varying Degrees of Renal Dysfunction.

Wu B, Lewis LD, Harvey RD, Rasmussen E, Gamelin E, Sun YN, Friberg G, Koyner JL, Dowlati A, Maitland ML.

Clin Pharmacol Ther. 2017 Aug;102(2):313-320. doi: 10.1002/cpt.617. Epub 2017 Jun 9.


First-in-human study of the antibody DR5 agonist DS-8273a in patients with advanced solid tumors.

Forero A, Bendell JC, Kumar P, Janisch L, Rosen M, Wang Q, Copigneaux C, Desai M, Senaldi G, Maitland ML.

Invest New Drugs. 2017 Jun;35(3):298-306. doi: 10.1007/s10637-016-0420-1. Epub 2017 Jan 3.


Improving clinical trial design through quantitative pharmacology.

Maitland ML.

Clin Adv Hematol Oncol. 2016 Aug;14(8):606-8. No abstract available.


Patient-Level Adverse Event Patterns in a Single-Institution Study of the Multi-Kinase Inhibitor Sorafenib.

Karovic S, Shiuan EF, Zhang SQ, Cao H, Maitland ML.

Clin Transl Sci. 2016 Oct;9(5):260-266. doi: 10.1111/cts.12408. Epub 2016 Jul 21.


First-in-human, open-label dose-escalation and dose-expansion study of the safety, pharmacokinetics, and antitumor effects of an oral ALK inhibitor ASP3026 in patients with advanced solid tumors.

Li T, LoRusso P, Maitland ML, Ou SH, Bahceci E, Ball HA, Park JW, Yuen G, Tolcher A.

J Hematol Oncol. 2016 Mar 10;9:23. doi: 10.1186/s13045-016-0254-5.


Comparative Effects of CT Imaging Measurement on RECIST End Points and Tumor Growth Kinetics Modeling.

Li CH, Bies RR, Wang Y, Sharma MR, Karovic S, Werk L, Edelman MJ, Miller AA, Vokes EE, Oto A, Ratain MJ, Schwartz LH, Maitland ML.

Clin Transl Sci. 2016 Feb;9(1):43-50. doi: 10.1111/cts.12384. Epub 2016 Jan 21.


Multikinase Inhibitors Induce Cutaneous Toxicity through OAT6-Mediated Uptake and MAP3K7-Driven Cell Death.

Zimmerman EI, Gibson AA, Hu S, Vasilyeva A, Orwick SJ, Du G, Mascara GP, Ong SS, Chen T, Vogel P, Inaba H, Maitland ML, Sparreboom A, Baker SD.

Cancer Res. 2016 Jan 1;76(1):117-26. doi: 10.1158/0008-5472.CAN-15-0694. Epub 2015 Dec 17.


Predicting Response to Histone Deacetylase Inhibitors Using High-Throughput Genomics.

Geeleher P, Loboda A, Lenkala D, Wang F, LaCroix B, Karovic S, Wang J, Nebozhyn M, Chisamore M, Hardwick J, Maitland ML, Huang RS.

J Natl Cancer Inst. 2015 Aug 21;107(11). pii: djv247. doi: 10.1093/jnci/djv247. Print 2015 Nov.


Serum C-Telopeptide Collagen Crosslinks and Plasma Soluble VEGFR2 as Pharmacodynamic Biomarkers in a Trial of Sequentially Administered Sunitinib and Cilengitide.

O'Donnell PH, Karovic S, Karrison TG, Janisch L, Levine MR, Harris PJ, Polite BN, Cohen EE, Fleming GF, Ratain MJ, Maitland ML.

Clin Cancer Res. 2015 Nov 15;21(22):5092-9. doi: 10.1158/1078-0432.CCR-15-0427. Epub 2015 Jul 21.


Identification of a variant in KDR associated with serum VEGFR2 and pharmacodynamics of Pazopanib.

Maitland ML, Xu CF, Cheng YC, Kistner-Griffin E, Ryan KA, Karrison TG, Das S, Torgerson D, Gamazon ER, Thomeas V, Levine MR, Wilson PA, Bing N, Liu Y, Cardon LR, Pandite LN, O'Connell JR, Cox NJ, Mitchell BD, Ratain MJ, Shuldiner AR.

Clin Cancer Res. 2015 Jan 15;21(2):365-72. doi: 10.1158/1078-0432.CCR-14-1683. Epub 2014 Nov 19.


Dose-finding and pharmacokinetic study to optimize the dosing of irinotecan according to the UGT1A1 genotype of patients with cancer.

Innocenti F, Schilsky RL, Ramírez J, Janisch L, Undevia S, House LK, Das S, Wu K, Turcich M, Marsh R, Karrison T, Maitland ML, Salgia R, Ratain MJ.

J Clin Oncol. 2014 Aug 1;32(22):2328-34. doi: 10.1200/JCO.2014.55.2307. Epub 2014 Jun 23.


Sorafenib dose escalation is not uniformly associated with blood pressure elevations in normotensive patients with advanced malignancies.

Karovic S, Wen Y, Karrison TG, Bakris GL, Levine MR, House LK, Wu K, Thomeas V, Rudek MA, Wright JJ, Cohen EE, Fleming GF, Ratain MJ, Maitland ML.

Clin Pharmacol Ther. 2014 Jul;96(1):27-35. doi: 10.1038/clpt.2014.63. Epub 2014 Mar 17.


Evaluation of a novel rash scale and a serum proteomic predictor in a randomized phase II trial of sequential or concurrent cetuximab and pemetrexed in previously treated non-small cell lung cancer.

Maitland ML, Levine MR, Lacouture ME, Wroblewski KE, Chung CH, Gordon IO, Szeto L, Ratko G, Soltani K, Kozloff MF, Hoffman PC, Salgia R, Carbone DP, Karrison TG, Vokes EE.

BMC Cancer. 2014 Jan 4;14:5. doi: 10.1186/1471-2407-14-5.


Technical considerations in the development of circulating peptides as pharmacodynamic biomarkers for angiogenesis inhibitors.

Thomeas V, Chow S, Gutierrez JO, Karovic S, Wroblewski K, Kistner-Griffin E, Karrison TG, Maitland ML.

J Clin Pharmacol. 2014 Jun;54(6):682-7. doi: 10.1002/jcph.254. Epub 2014 Jan 17.


Bayesian inference for longitudinal data with non-parametric treatment effects.

Müller P, Quintana FA, Rosner GL, Maitland ML.

Biostatistics. 2014 Apr;15(2):341-52. doi: 10.1093/biostatistics/kxt049. Epub 2013 Nov 26.


Institutional Profile: University of Chicago Center for Personalized Therapeutics: research, education and implementation science.

Dolan ME, Maitland ML, O'Donnell PH, Nakamura Y, Cox NJ, Ratain MJ.

Pharmacogenomics. 2013 Sep;14(12):1383-7. doi: 10.2217/pgs.13.134.


Effects of vascular endothelial growth factor signaling inhibition on human erythropoiesis.

Bhatta SS, Wroblewski KE, Agarwal KL, Sit L, Cohen EE, Seiwert TY, Karrison T, Bakris GL, Ratain MJ, Vokes EE, Maitland ML.

Oncologist. 2013;18(8):965-70. doi: 10.1634/theoncologist.2013-0006. Epub 2013 Jul 30.


Time to tumor growth: a model end point and new metric system for oncology clinical trials.

Maitland ML, Schwartz LH, Ratain MJ.

J Clin Oncol. 2013 Jun 10;31(17):2070-2. doi: 10.1200/JCO.2013.49.3635. Epub 2013 May 6. No abstract available.


Evaluation of food effect on pharmacokinetics of vismodegib in advanced solid tumor patients.

Sharma MR, Karrison TG, Kell B, Wu K, Turcich M, Geary D, Kang SP, Takebe N, Graham RA, Maitland ML, Schilsky RL, Ratain MJ, Cohen EE.

Clin Cancer Res. 2013 Jun 1;19(11):3059-67. doi: 10.1158/1078-0432.CCR-12-3829. Epub 2013 Apr 3.


More sound cancer therapy biomarker development with active noise control.

Maitland ML.

Oncologist. 2013;18(3):239-41. doi: 10.1634/theoncologist.2013-0030. Epub 2013 Mar 13. No abstract available.


Estimation of renal cell carcinoma treatment effects from disease progression modeling.

Maitland ML, Wu K, Sharma MR, Jin Y, Kang SP, Stadler WM, Karrison TG, Ratain MJ, Bies RR.

Clin Pharmacol Ther. 2013 Apr;93(4):345-51. doi: 10.1038/clpt.2012.263. Epub 2012 Dec 27.


Cancer pharmacogenomics: strategies and challenges.

Wheeler HE, Maitland ML, Dolan ME, Cox NJ, Ratain MJ.

Nat Rev Genet. 2013 Jan;14(1):23-34. doi: 10.1038/nrg3352. Epub 2012 Nov 27. Review.


Models of excellence: improving oncology drug development.

Sharma MR, Maitland ML, Ratain MJ.

Clin Pharmacol Ther. 2012 Nov;92(5):548-50. doi: 10.1038/clpt.2012.99.


Why RECIST works and why it should stay--reply to counterpoint.

Sharma MR, Maitland ML, Ratain MJ.

Cancer Res. 2012 Oct 15;72(20):5158. doi: 10.1158/0008-5472.CAN-12-1988. Epub 2012 Sep 4. No abstract available.


RECIST: no longer the sharpest tool in the oncology clinical trials toolbox---point.

Sharma MR, Maitland ML, Ratain MJ.

Cancer Res. 2012 Oct 15;72(20):5145-9; discussion 5150. doi: 10.1158/0008-5472.CAN-12-0058. Epub 2012 Sep 4.


Phase I studies of sirolimus alone or in combination with pharmacokinetic modulators in advanced cancer patients.

Cohen EE, Wu K, Hartford C, Kocherginsky M, Eaton KN, Zha Y, Nallari A, Maitland ML, Fox-Kay K, Moshier K, House L, Ramirez J, Undevia SD, Fleming GF, Gajewski TF, Ratain MJ.

Clin Cancer Res. 2012 Sep 1;18(17):4785-93. doi: 10.1158/1078-0432.CCR-12-0110. Epub 2012 Aug 7.


Advances in biomarkers for targeted agents.

Maitland ML.

Clin Adv Hematol Oncol. 2011 Sep;9(9):688-90. No abstract available.


Management of cardiac toxicity in patients receiving vascular endothelial growth factor signaling pathway inhibitors.

Steingart RM, Bakris GL, Chen HX, Chen MH, Force T, Ivy SP, Leier CV, Liu G, Lenihan D, Lindenfeld J, Maitland ML, Remick SC, Tang WH.

Am Heart J. 2012 Feb;163(2):156-63. doi: 10.1016/j.ahj.2011.10.018. Review.


Resampling phase III data to assess phase II trial designs and endpoints.

Sharma MR, Karrison TG, Jin Y, Bies RR, Maitland ML, Stadler WM, Ratain MJ.

Clin Cancer Res. 2012 Apr 15;18(8):2309-15. doi: 10.1158/1078-0432.CCR-11-1815. Epub 2012 Jan 27.


Sorafenib inhibits neuroblastoma cell proliferation and signaling, blocks angiogenesis, and impairs tumor growth.

Kakodkar NC, Peddinti RR, Tian Y, Guerrero LJ, Chlenski A, Yang Q, Salwen HR, Maitland ML, Cohn SL.

Pediatr Blood Cancer. 2012 Oct;59(4):642-7. doi: 10.1002/pbc.24004. Epub 2011 Dec 6.


Clinical trials in the era of personalized oncology.

Maitland ML, Schilsky RL.

CA Cancer J Clin. 2011 Nov-Dec;61(6):365-81. doi: 10.3322/caac.20135. Epub 2011 Oct 27.


Sunitinib, hypertension, and heart failure: a model for kinase inhibitor-mediated cardiotoxicity.

Gupta R, Maitland ML.

Curr Hypertens Rep. 2011 Dec;13(6):430-5. doi: 10.1007/s11906-011-0229-4. Review.


A time to keep and a time to cast away categories of tumor response.

Maitland ML, Bies RR, Barrett JS.

J Clin Oncol. 2011 Aug 10;29(23):3109-11. doi: 10.1200/JCO.2011.36.3887. Epub 2011 Jul 5. No abstract available.


Two drug interaction studies of sirolimus in combination with sorafenib or sunitinib in patients with advanced malignancies.

Gangadhar TC, Cohen EE, Wu K, Janisch L, Geary D, Kocherginsky M, House LK, Ramirez J, Undevia SD, Maitland ML, Fleming GF, Ratain MJ.

Clin Cancer Res. 2011 Apr 1;17(7):1956-63. doi: 10.1158/1078-0432.CCR-10-2061. Epub 2011 Mar 29.


Analysis of the yield of phase II combination therapy trials in medical oncology.

Maitland ML, Hudoba C, Snider KL, Ratain MJ.

Clin Cancer Res. 2010 Nov 1;16(21):5296-302. doi: 10.1158/1078-0432.CCR-10-0669. Epub 2010 Sep 13. Review.


Volumes to learn: advancing therapeutics with innovative computed tomography image data analysis.

Maitland ML.

Clin Cancer Res. 2010 Sep 15;16(18):4493-5. doi: 10.1158/1078-0432.CCR-10-1548. Epub 2010 Jul 19.


Kinase inhibition-related adverse events predicted from in vitro kinome and clinical trial data.

Yang X, Huang Y, Crowson M, Li J, Maitland ML, Lussier YA.

J Biomed Inform. 2010 Jun;43(3):376-84. doi: 10.1016/j.jbi.2010.04.006. Epub 2010 May 1.


Initial assessment, surveillance, and management of blood pressure in patients receiving vascular endothelial growth factor signaling pathway inhibitors.

Maitland ML, Bakris GL, Black HR, Chen HX, Durand JB, Elliott WJ, Ivy SP, Leier CV, Lindenfeld J, Liu G, Remick SC, Steingart R, Tang WH; Cardiovascular Toxicities Panel, Convened by the Angiogenesis Task Force of the National Cancer Institute Investigational Drug Steering Committee.

J Natl Cancer Inst. 2010 May 5;102(9):596-604. doi: 10.1093/jnci/djq091. Epub 2010 Mar 29.


A proposed EGFR inhibitor dermatologic adverse event-specific grading scale from the MASCC skin toxicity study group.

Lacouture ME, Maitland ML, Segaert S, Setser A, Baran R, Fox LP, Epstein JB, Barasch A, Einhorn L, Wagner L, West DP, Rapoport BL, Kris MG, Basch E, Eaby B, Kurtin S, Olsen EA, Chen A, Dancey JE, Trotti A.

Support Care Cancer. 2010 Apr;18(4):509-22. doi: 10.1007/s00520-009-0744-x. Epub 2010 Feb 10.


Vascular endothelial growth factor pathway.

Maitland ML, Lou XJ, Ramirez J, Desai AA, Berlin DS, McLeod HL, Weichselbaum RR, Ratain MJ, Altman RB, Klein TE.

Pharmacogenet Genomics. 2010 May;20(5):346-9. doi: 10.1097/FPC.0b013e3283364ed7. Review. No abstract available.


A dosing/cross-development study of the multikinase inhibitor sorafenib in patients with pulmonary arterial hypertension.

Gomberg-Maitland M, Maitland ML, Barst RJ, Sugeng L, Coslet S, Perrino TJ, Bond L, Lacouture ME, Archer SL, Ratain MJ.

Clin Pharmacol Ther. 2010 Mar;87(3):303-10. doi: 10.1038/clpt.2009.217. Epub 2009 Dec 9.


Carboplatin and Paclitaxel in combination with either vorinostat or placebo for first-line therapy of advanced non-small-cell lung cancer.

Ramalingam SS, Maitland ML, Frankel P, Argiris AE, Koczywas M, Gitlitz B, Thomas S, Espinoza-Delgado I, Vokes EE, Gandara DR, Belani CP.

J Clin Oncol. 2010 Jan 1;28(1):56-62. doi: 10.1200/JCO.2009.24.9094. Epub 2009 Nov 23.


Other paradigms: better treatments are identified by better trials: the value of randomized phase II studies.

Sharma MR, Maitland ML, Ratain MJ.

Cancer J. 2009 Sep-Oct;15(5):426-30. doi: 10.1097/PPO.0b013e3181b9c5d5. Review.


Ambulatory monitoring detects sorafenib-induced blood pressure elevations on the first day of treatment.

Maitland ML, Kasza KE, Karrison T, Moshier K, Sit L, Black HR, Undevia SD, Stadler WM, Elliott WJ, Ratain MJ.

Clin Cancer Res. 2009 Oct 1;15(19):6250-7. doi: 10.1158/1078-0432.CCR-09-0058. Epub 2009 Sep 22.


Inflammation, growth factors, and pulmonary vascular remodeling.

Hassoun PM, Mouthon L, Barberà JA, Eddahibi S, Flores SC, Grimminger F, Jones PL, Maitland ML, Michelakis ED, Morrell NW, Newman JH, Rabinovitch M, Schermuly R, Stenmark KR, Voelkel NF, Yuan JX, Humbert M.

J Am Coll Cardiol. 2009 Jun 30;54(1 Suppl):S10-9. doi: 10.1016/j.jacc.2009.04.006. Review.


Cardiovascular toxicities: clues to optimal administration of vascular endothelial growth factor signaling pathway inhibitors.

Snider KL, Maitland ML.

Target Oncol. 2009 Apr;4(2):67-76. doi: 10.1007/s11523-009-0106-0. Epub 2009 Apr 17. Review.

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