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Clinical Evolution of Epithelial-Mesenchymal Transition in Human Carcinomas.

Navas T, Kinders RJ, Lawrence SM, Ferry-Galow KV, Borgel S, Hollingshead MG, Srivastava AK, Alcoser SY, Makhlouf HR, Chuaqui R, Wilsker DF, Konaté MM, Miller SB, Voth AR, Chen L, Vilimas T, Subramanian J, Rubinstein L, Kummar S, Chen AP, Bottaro DP, Doroshow JH, Parchment RE.

Cancer Res. 2020 Jan 15;80(2):304-318. doi: 10.1158/0008-5472.CAN-18-3539. Epub 2019 Nov 15.


Evaluation of Pharmacodynamic Responses to Cancer Therapeutic Agents Using DNA Damage Markers.

Wilsker DF, Barrett AM, Dull AB, Lawrence SM, Hollingshead MG, Chen A, Kummar S, Parchment RE, Doroshow JH, Kinders RJ.

Clin Cancer Res. 2019 May 15;25(10):3084-3095. doi: 10.1158/1078-0432.CCR-18-2523. Epub 2019 Feb 21.


NCI Comparative Oncology Program Testing of Non-Camptothecin Indenoisoquinoline Topoisomerase I Inhibitors in Naturally Occurring Canine Lymphoma.

Burton JH, Mazcko C, LeBlanc A, Covey JM, Ji J, Kinders RJ, Parchment RE, Khanna C, Paoloni M, Lana S, Weishaar K, London C, Kisseberth W, Krick E, Vail D, Childress M, Bryan JN, Barber L, Ehrhart EJ, Kent M, Fan T, Kow K, Northup N, Wilson-Robles H, Tomaszewski J, Holleran JL, Muzzio M, Eiseman J, Beumer JH, Doroshow JH, Pommier Y.

Clin Cancer Res. 2018 Dec 1;24(23):5830-5840. doi: 10.1158/1078-0432.CCR-18-1498. Epub 2018 Jul 30.


Novel antibody reagents for characterization of drug- and tumor microenvironment-induced changes in epithelial-mesenchymal transition and cancer stem cells.

Navas T, Pfister TD, Colantonio S, Aziz A, Dieckman L, Saul RG, Kaczmarczyk J, Borgel S, Alcoser SY, Hollingshead MG, Lee YH, Bottaro DP, Hiltke T, Whiteley G, Takebe N, Kinders RJ, Parchment RE, Tomaszewski JE, Doroshow JH.

PLoS One. 2018 Jun 21;13(6):e0199361. doi: 10.1371/journal.pone.0199361. eCollection 2018.


Development of a quantitative pharmacodynamic assay for apoptosis in fixed tumor tissue and its application in distinguishing cytotoxic drug-induced DNA double strand breaks from DNA double strand breaks associated with apoptosis.

Dull AB, Wilsker D, Hollingshead M, Mazcko C, Annunziata CM, LeBlanc AK, Doroshow JH, Kinders RJ, Parchment RE.

Oncotarget. 2018 Mar 30;9(24):17104-17116. doi: 10.18632/oncotarget.24936. eCollection 2018 Mar 30.


Molecular Pharmacodynamics-Guided Scheduling of Biologically Effective Doses: A Drug Development Paradigm Applied to MET Tyrosine Kinase Inhibitors.

Srivastava AK, Hollingshead MG, Govindharajulu JP, Covey JM, Liston D, Simpson MA, Peggins JO, Bottaro DP, Wright JJ, Kinders RJ, Doroshow JH, Parchment RE.

Mol Cancer Ther. 2018 Mar;17(3):698-709. doi: 10.1158/1535-7163.MCT-17-0552. Epub 2018 Feb 14.


Small cell lung carcinoma cell line screen of etoposide/carboplatin plus a third agent.

Teicher BA, Silvers T, Selby M, Delosh R, Laudeman J, Ogle C, Reinhart R, Parchment R, Krushkal J, Sonkin D, Rubinstein L, Morris J, Evans D.

Cancer Med. 2017 Aug;6(8):1952-1964. doi: 10.1002/cam4.1131. Epub 2017 Aug 1.


Antibody-independent capture of circulating tumor cells of non-epithelial origin with the ApoStream® system.

Balasubramanian P, Kinders RJ, Kummar S, Gupta V, Hasegawa D, Menachery A, Lawrence SM, Wang L, Ferry-Galow K, Davis D, Parchment RE, Tomaszewski JE, Doroshow JH.

PLoS One. 2017 Apr 12;12(4):e0175414. doi: 10.1371/journal.pone.0175414. eCollection 2017.


3D Models of the NCI60 Cell Lines for Screening Oncology Compounds.

Selby M, Delosh R, Laudeman J, Ogle C, Reinhart R, Silvers T, Lawrence S, Kinders R, Parchment R, Teicher BA, Evans DM.

SLAS Discov. 2017 Jun;22(5):473-483. doi: 10.1177/2472555217697434. Epub 2017 Mar 13.


Effective implementation of novel MET pharmacodynamic assays in translational studies.

Srivastava AK, Navas T, Herrick WG, Hollingshead MG, Bottaro DP, Doroshow JH, Parchment RE.

Ann Transl Med. 2017 Jan;5(1):3. doi: 10.21037/atm.2016.12.78. Review.


Phosphorylated fraction of H2AX as a measurement for DNA damage in cancer cells and potential applications of a novel assay.

Ji J, Zhang Y, Redon CE, Reinhold WC, Chen AP, Fogli LK, Holbeck SL, Parchment RE, Hollingshead M, Tomaszewski JE, Dudon Q, Pommier Y, Doroshow JH, Bonner WM.

PLoS One. 2017 Feb 3;12(2):e0171582. doi: 10.1371/journal.pone.0171582. eCollection 2017.


Pharmacodynamic endpoints as clinical trial objectives to answer important questions in oncology drug development.

Parchment RE, Doroshow JH.

Semin Oncol. 2016 Aug;43(4):514-25. doi: 10.1053/j.seminoncol.2016.07.002. Epub 2016 Jul 26. Review.


Immuno-pharmacodynamics for evaluating mechanism of action and developing immunotherapy combinations.

Parchment RE, Voth AR, Doroshow JH, Berzofsky JA.

Semin Oncol. 2016 Aug;43(4):501-13. doi: 10.1053/j.seminoncol.2016.06.008. Epub 2016 Jun 16. Review.


Pharmacodynamic analyses in a multi-laboratory network: lessons from the poly(ADP-ribose) assay.

Ferry-Galow KV, Ji J, Kinders RJ, Zhang Y, Czambel RK, Schmitz JC, Herzog J, Evrard YA, Parchment RE.

Semin Oncol. 2016 Aug;43(4):492-500. doi: 10.1053/j.seminoncol.2016.06.007. Epub 2016 Jun 15.


The root causes of pharmacodynamic assay failure.

Ferry-Galow KV, Makhlouf HR, Wilsker DF, Lawrence SM, Pfister TD, Marrero AM, Bigelow KM, Yutzy WH, Ji JJ, Butcher DO, Gouker BA, Kummar S, Chen AP, Kinders RJ, Parchment RE, Doroshow JH.

Semin Oncol. 2016 Aug;43(4):484-91. doi: 10.1053/j.seminoncol.2016.06.006. Epub 2016 Jun 15. Review.


Theory and practice of clinical pharmacodynamics in oncology drug development.

Parchment RE, Doroshow JH.

Semin Oncol. 2016 Aug;43(4):427-35. doi: 10.1053/j.seminoncol.2016.07.001. Epub 2016 Jul 26.


Clinical and pharmacologic evaluation of two dosing schedules of indotecan (LMP400), a novel indenoisoquinoline, in patients with advanced solid tumors.

Kummar S, Chen A, Gutierrez M, Pfister TD, Wang L, Redon C, Bonner WM, Yutzy W, Zhang Y, Kinders RJ, Ji J, Allen D, Covey JM, Eiseman JL, Holleran JL, Beumer JH, Rubinstein L, Collins J, Tomaszewski J, Parchment R, Pommier Y, Doroshow JH.

Cancer Chemother Pharmacol. 2016 Jul;78(1):73-81. doi: 10.1007/s00280-016-2998-6. Epub 2016 May 11.


Pharmacodynamic Response of the MET/HGF Receptor to Small-Molecule Tyrosine Kinase Inhibitors Examined with Validated, Fit-for-Clinic Immunoassays.

Srivastava AK, Hollingshead MG, Weiner J, Navas T, Evrard YA, Khin SA, Ji JJ, Zhang Y, Borgel S, Pfister TD, Kinders RJ, Bottaro DP, Linehan WM, Tomaszewski JE, Doroshow JH, Parchment RE.

Clin Cancer Res. 2016 Jul 15;22(14):3683-94. doi: 10.1158/1078-0432.CCR-15-2323. Epub 2016 Mar 21.


Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of the Poly(ADP-ribose) Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Combination with Irinotecan in Patients with Advanced Solid Tumors.

LoRusso PM, Li J, Burger A, Heilbrun LK, Sausville EA, Boerner SA, Smith D, Pilat MJ, Zhang J, Tolaney SM, Cleary JM, Chen AP, Rubinstein L, Boerner JL, Bowditch A, Cai D, Bell T, Wolanski A, Marrero AM, Zhang Y, Ji J, Ferry-Galow K, Kinders RJ, Parchment RE, Shapiro GI.

Clin Cancer Res. 2016 Jul 1;22(13):3227-37. doi: 10.1158/1078-0432.CCR-15-0652. Epub 2016 Feb 3.


Human CD34(+) progenitor hematopoiesis in liquid culture for in vitro assessment of drug-induced myelotoxicity.

Guo L, Hamre J 3rd, Davis M, Parchment RE.

Toxicol In Vitro. 2016 Mar;31:103-13. doi: 10.1016/j.tiv.2015.11.017. Epub 2015 Nov 23.


Effect of a Smac Mimetic (TL32711, Birinapant) on the Apoptotic Program and Apoptosis Biomarkers Examined with Validated Multiplex Immunoassays Fit for Clinical Use.

Srivastava AK, Jaganathan S, Stephen L, Hollingshead MG, Layhee A, Damour E, Govindharajulu JP, Donohue J, Esposito D, Mapes JP, Kinders RJ, Takebe N, Tomaszewski JE, Kummar S, Doroshow JH, Parchment RE.

Clin Cancer Res. 2016 Feb 15;22(4):1000-10. doi: 10.1158/1078-0432.CCR-14-3156. Epub 2015 Oct 7.


Implementation of validated pharmacodynamic assays in multiple laboratories: challenges, successes, and limitations.

Kinders R, Ferry-Galow K, Wang L, Srivastava AK, Ji JJ, Parchment RE.

Clin Cancer Res. 2014 May 15;20(10):2578-86. doi: 10.1158/1078-0432.CCR-14-0476.


Validation of a hypoxia-inducible factor-1 alpha specimen collection procedure and quantitative enzyme-linked immunosorbent assay in solid tumor tissues.

Park SR, Kinders RJ, Khin S, Hollingshead M, Antony S, Parchment RE, Tomaszewski JE, Kummar S, Doroshow JH.

Anal Biochem. 2014 Aug 15;459:1-11. doi: 10.1016/j.ab.2014.04.025. Epub 2014 May 4.


Analyses of the combination of 6-MP and dasatinib in cell culture.

Kaur G, Behrsing H, Parchment RE, Millin MD, Teicher BA.

Int J Oncol. 2013 Jul;43(1):13-22. doi: 10.3892/ijo.2013.1930. Epub 2013 May 2.


Development and validation of an immunoassay for quantification of topoisomerase I in solid tumor tissues.

Pfister TD, Hollingshead M, Kinders RJ, Zhang Y, Evrard YA, Ji J, Khin SA, Borgel S, Stotler H, Carter J, Divelbiss R, Kummar S, Pommier Y, Parchment RE, Tomaszewski JE, Doroshow JH.

PLoS One. 2012;7(12):e50494. doi: 10.1371/journal.pone.0050494. Epub 2012 Dec 28.


Advances in using PARP inhibitors to treat cancer.

Kummar S, Chen A, Parchment RE, Kinders RJ, Ji J, Tomaszewski JE, Doroshow JH.

BMC Med. 2012 Mar 9;10:25. doi: 10.1186/1741-7015-10-25. Review.


A phase I study of veliparib in combination with metronomic cyclophosphamide in adults with refractory solid tumors and lymphomas.

Kummar S, Ji J, Morgan R, Lenz HJ, Puhalla SL, Belani CP, Gandara DR, Allen D, Kiesel B, Beumer JH, Newman EM, Rubinstein L, Chen A, Zhang Y, Wang L, Kinders RJ, Parchment RE, Tomaszewski JE, Doroshow JH.

Clin Cancer Res. 2012 Mar 15;18(6):1726-34. doi: 10.1158/1078-0432.CCR-11-2821. Epub 2012 Feb 3.


Modeling pharmacodynamic response to the poly(ADP-Ribose) polymerase inhibitor ABT-888 in human peripheral blood mononuclear cells.

Ji J, Kinders RJ, Zhang Y, Rubinstein L, Kummar S, Parchment RE, Tomaszewski JE, Doroshow JH.

PLoS One. 2011;6(10):e26152. doi: 10.1371/journal.pone.0026152. Epub 2011 Oct 10.


Phase I study of PARP inhibitor ABT-888 in combination with topotecan in adults with refractory solid tumors and lymphomas.

Kummar S, Chen A, Ji J, Zhang Y, Reid JM, Ames M, Jia L, Weil M, Speranza G, Murgo AJ, Kinders R, Wang L, Parchment RE, Carter J, Stotler H, Rubinstein L, Hollingshead M, Melillo G, Pommier Y, Bonner W, Tomaszewski JE, Doroshow JH.

Cancer Res. 2011 Sep 1;71(17):5626-34. doi: 10.1158/0008-5472.CAN-11-1227. Epub 2011 Jul 27.


Development of a validated immunofluorescence assay for γH2AX as a pharmacodynamic marker of topoisomerase I inhibitor activity.

Kinders RJ, Hollingshead M, Lawrence S, Ji J, Tabb B, Bonner WM, Pommier Y, Rubinstein L, Evrard YA, Parchment RE, Tomaszewski J, Doroshow JH; National Cancer Institute Phase 0 Clinical Trials Team.

Clin Cancer Res. 2010 Nov 15;16(22):5447-57. doi: 10.1158/1078-0432.CCR-09-3076. Epub 2010 Oct 5.


Histone gammaH2AX and poly(ADP-ribose) as clinical pharmacodynamic biomarkers.

Redon CE, Nakamura AJ, Zhang YW, Ji JJ, Bonner WM, Kinders RJ, Parchment RE, Doroshow JH, Pommier Y.

Clin Cancer Res. 2010 Sep 15;16(18):4532-42. doi: 10.1158/1078-0432.CCR-10-0523. Epub 2010 Sep 7. Review.


Prevalidation of the rat CFU-GM assay for in vitro toxicology applications.

Pessina A, Bonomi A, Cavicchini L, Albella B, Cerrato L, Parent-Massin D, Sibiril Y, Parchment R, Behrsing H, Verderio P, Pizzamiglio S, Giangreco M, Baglio C, Coccè V, Sisto F, Gribaldo L.

Altern Lab Anim. 2010 May;38(2):105-17.


The statistics of phase 0 trials.

Rubinstein LV, Steinberg SM, Kummar S, Kinders R, Parchment RE, Murgo AJ, Tomaszewski JE, Doroshow JH.

Stat Med. 2010 May 10;29(10):1072-6. doi: 10.1002/sim.3840.


Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents.

Dancey JE, Dobbin KK, Groshen S, Jessup JM, Hruszkewycz AH, Koehler M, Parchment R, Ratain MJ, Shankar LK, Stadler WM, True LD, Gravell A, Grever MR; Biomarkers Task Force of the NCI Investigational Drug Steering Committee.

Clin Cancer Res. 2010 Mar 15;16(6):1745-55. doi: 10.1158/1078-0432.CCR-09-2167. Epub 2010 Mar 9.


Exon array analyses across the NCI-60 reveal potential regulation of TOP1 by transcription pausing at guanosine quartets in the first intron.

Reinhold WC, Mergny JL, Liu H, Ryan M, Pfister TD, Kinders R, Parchment R, Doroshow J, Weinstein JN, Pommier Y.

Cancer Res. 2010 Mar 15;70(6):2191-203. doi: 10.1158/0008-5472.CAN-09-3528. Epub 2010 Mar 9.


Monitoring drug-induced gammaH2AX as a pharmacodynamic biomarker in individual circulating tumor cells.

Wang LH, Pfister TD, Parchment RE, Kummar S, Rubinstein L, Evrard YA, Gutierrez ME, Murgo AJ, Tomaszewski JE, Doroshow JH, Kinders RJ.

Clin Cancer Res. 2010 Feb 1;16(3):1073-84. doi: 10.1158/1078-0432.CCR-09-2799. Epub 2010 Jan 26.


In vitro comparison of O4-benzylfolate modulated, BCNU-induced toxicity in human bone marrow using CFU-GM and tumor cell lines.

Behrsing HP, Furniss MJ, Robillard KA, Tomaszewski JE, Parchment RE.

Cancer Chemother Pharmacol. 2010 May;65(6):1083-91. doi: 10.1007/s00280-009-1113-7. Epub 2009 Aug 29.


Synergistic antitumor activity of oncolytic reovirus and chemotherapeutic agents in non-small cell lung cancer cells.

Sei S, Mussio JK, Yang QE, Nagashima K, Parchment RE, Coffey MC, Shoemaker RH, Tomaszewski JE.

Mol Cancer. 2009 Jul 14;8:47. doi: 10.1186/1476-4598-8-47.


Topoisomerase I levels in the NCI-60 cancer cell line panel determined by validated ELISA and microarray analysis and correlation with indenoisoquinoline sensitivity.

Pfister TD, Reinhold WC, Agama K, Gupta S, Khin SA, Kinders RJ, Parchment RE, Tomaszewski JE, Doroshow JH, Pommier Y.

Mol Cancer Ther. 2009 Jul;8(7):1878-84. doi: 10.1158/1535-7163.MCT-09-0016. Epub 2009 Jul 7.


Increased antitumor activity of bevacizumab in combination with hypoxia inducible factor-1 inhibition.

Rapisarda A, Hollingshead M, Uranchimeg B, Bonomi CA, Borgel SD, Carter JP, Gehrs B, Raffeld M, Kinders RJ, Parchment R, Anver MR, Shoemaker RH, Melillo G.

Mol Cancer Ther. 2009 Jul;8(7):1867-77. doi: 10.1158/1535-7163.MCT-09-0274. Epub 2009 Jul 7.


Phase 0 clinical trial of the poly (ADP-ribose) polymerase inhibitor ABT-888 in patients with advanced malignancies.

Kummar S, Kinders R, Gutierrez ME, Rubinstein L, Parchment RE, Phillips LR, Ji J, Monks A, Low JA, Chen A, Murgo AJ, Collins J, Steinberg SM, Eliopoulos H, Giranda VL, Gordon G, Helman L, Wiltrout R, Tomaszewski JE, Doroshow JH.

J Clin Oncol. 2009 Jun 1;27(16):2705-11. doi: 10.1200/JCO.2008.19.7681. Epub 2009 Apr 13.


Phase II trial of fenretinide (NSC 374551) in patients with recurrent small cell lung cancer.

Schneider BJ, Worden FP, Gadgeel SM, Parchment RE, Hodges CM, Zwiebel J, Dunn RL, Wozniak AJ, Kraut MJ, Kalemkerian GP.

Invest New Drugs. 2009 Dec;27(6):571-8. doi: 10.1007/s10637-009-9228-6. Epub 2009 Feb 19.


Topoisomerase I inhibitors and drug resistance.

Parchment RE, Pessina A.

Cytotechnology. 1998 Sep;27(1-3):149-64. doi: 10.1023/A:1008008719699.


Preclinical modeling of a phase 0 clinical trial: qualification of a pharmacodynamic assay of poly (ADP-ribose) polymerase in tumor biopsies of mouse xenografts.

Kinders RJ, Hollingshead M, Khin S, Rubinstein L, Tomaszewski JE, Doroshow JH, Parchment RE; National Cancer Institute Phase 0 Clinical Trials Team.

Clin Cancer Res. 2008 Nov 1;14(21):6877-85. doi: 10.1158/1078-0432.CCR-08-0214.


Designing phase 0 cancer clinical trials.

Murgo AJ, Kummar S, Rubinstein L, Gutierrez M, Collins J, Kinders R, Parchment RE, Ji J, Steinberg SM, Yang SX, Hollingshead M, Chen A, Helman L, Wiltrout R, Tomaszewski JE, Doroshow JH.

Clin Cancer Res. 2008 Jun 15;14(12):3675-82. doi: 10.1158/1078-0432.CCR-07-4560.


Oncologic phase 0 trials incorporating clinical pharmacodynamics: from concept to patient.

Doroshow JH, Parchment RE.

Clin Cancer Res. 2008 Jun 15;14(12):3658-63. doi: 10.1158/1078-0432.CCR-07-4562.


Phase 0 clinical trials: conceptions and misconceptions.

Kummar S, Rubinstein L, Kinders R, Parchment RE, Gutierrez ME, Murgo AJ, Ji J, Mroczkowski B, Pickeral OK, Simpson M, Hollingshead M, Yang SX, Helman L, Wiltrout R, Collins J, Tomaszewski JE, Doroshow JH.

Cancer J. 2008 May-Jun;14(3):133-7. doi: 10.1097/PPO.0b013e318172d6f3. Review.


Integration of in vivo and in vitro approaches to characterize the toxicity of Antalarmin, a corticotropin-releasing hormone receptor antagonist.

Horn TL, Harder JB, Johnson WD, Curry PT, Parchment RE, Morrissey RL, Mellick PW, Calis KA, Gold PW, Rice KC, Contoreggi C, Charney DS, Cizza G, Glaze ER, Tomaszewski JE, McCormick DL.

Toxicology. 2008 Jun 3;248(1):8-17. doi: 10.1016/j.tox.2008.03.002. Epub 2008 Mar 13.


Phase 0 clinical trials in cancer drug development: from FDA guidance to clinical practice.

Kinders R, Parchment RE, Ji J, Kummar S, Murgo AJ, Gutierrez M, Collins J, Rubinstein L, Pickeral O, Steinberg SM, Yang S, Hollingshead M, Chen A, Helman L, Wiltrout R, Simpson M, Tomaszewski JE, Doroshow JH.

Mol Interv. 2007 Dec;7(6):325-34. doi: 10.1124/mi.7.6.9. Review.


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