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James Mark Cleary, Ph.D., M.D.

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Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
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  1. Aguirre AJ, Nowak JA, Camarda ND, Moffitt RA, Ghazani AA, Hazar-Rethinam M, Raghavan S, Kim J, Brais LK, Ragon D, Welch MW, Reilly E, McCabe D, Marini L, Anderka K, Helvie K, Oliver N, Babic A, Da Silva A, Nadres B, Van Seventer EE, Shahzade HA, St Pierre JP, Burke KP, Clancy T, Cleary JM, Doyle LA, Jajoo K, McCleary NJ, Meyerhardt JA, Murphy JE, Ng K, Patel AK, Perez K, Rosenthal MH, Rubinson DA, Ryou M, Shapiro GI, Sicinska E, Silverman SG, Nagy RJ, Lanman RB, Knoerzer D, Welsch DJ, Yurgelun MB, Fuchs CS, Garraway LA, Getz G, Hornick JL, Johnson BE, Kulke MH, Mayer RJ, Miller JW, Shyn PB, Tuveson DA, Wagle N, Yeh JJ, Hahn WC, Corcoran RB, Carter SL, Wolpin BM. Real-time Genomic Characterization of Advanced Pancreatic Cancer to Enable Precision Medicine. Cancer Discov. 2018 Sep; 8(9):1096-1111. PMID: 29903880.
    View in: PubMed
  2. Jenkins RW, Aref AR, Lizotte PH, Ivanova E, Stinson S, Zhou CW, Bowden M, Deng J, Liu H, Miao D, He MX, Walker W, Zhang G, Tian T, Cheng C, Wei Z, Palakurthi S, Bittinger M, Vitzthum H, Kim JW, Merlino A, Quinn M, Venkataramani C, Kaplan JA, Portell A, Gokhale PC, Phillips B, Smart A, Rotem A, Jones RE, Keogh L, Anguiano M, Stapleton L, Jia Z, Barzily-Rokni M, Cañadas I, Thai TC, Hammond MR, Vlahos R, Wang ES, Zhang H, Li S, Hanna GJ, Huang W, Hoang MP, Piris A, Eliane JP, Stemmer-Rachamimov AO, Cameron L, Su MJ, Shah P, Izar B, Thakuria M, LeBoeuf NR, Rabinowits G, Gunda V, Parangi S, Cleary JM, Miller BC, Kitajima S, Thummalapalli R, Miao B, Barbie TU, Sivathanu V, Wong J, Richards WG, Bueno R, Yoon CH, Miret J, Herlyn M, Garraway LA, Van Allen EM, Freeman GJ, Kirschmeier PT, Lorch JH, Ott PA, Hodi FS, Flaherty KT, Kamm RD, Boland GM, Wong KK, Dornan D, Paweletz CP, Barbie DA. Ex Vivo Profiling of PD-1 Blockade Using Organotypic Tumor Spheroids. Cancer Discov. 2018 Feb; 8(2):196-215. PMID: 29101162.
    View in: PubMed
  3. Mita MM, Mita AC, Moseley JL, Poon J, Small KA, Jou YM, Kirschmeier P, Zhang D, Zhu Y, Statkevich P, Sankhala KK, Sarantopoulos J, Cleary JM, Chirieac LR, Rodig SJ, Bannerji R, Shapiro GI. Phase 1 safety, pharmacokinetic and pharmacodynamic study of the cyclin-dependent kinase inhibitor dinaciclib administered every three weeks in patients with advanced malignancies. Br J Cancer. 2017 Oct 24; 117(9):1258-1268. PMID: 28859059.
    View in: PubMed
  4. Viswanathan VS, Ryan MJ, Dhruv HD, Gill S, Eichhoff OM, Seashore-Ludlow B, Kaffenberger SD, Eaton JK, Shimada K, Aguirre AJ, Viswanathan SR, Chattopadhyay S, Tamayo P, Yang WS, Rees MG, Chen S, Boskovic ZV, Javaid S, Huang C, Wu X, Tseng YY, Roider EM, Gao D, Cleary JM, Wolpin BM, Mesirov JP, Haber DA, Engelman JA, Boehm JS, Kotz JD, Hon CS, Chen Y, Hahn WC, Levesque MP, Doench JG, Berens ME, Shamji AF, Clemons PA, Stockwell BR, Schreiber SL. Dependency of a therapy-resistant state of cancer cells on a lipid peroxidase pathway. Nature. 2017 07 27; 547(7664):453-457. PMID: 28678785.
    View in: PubMed
  5. Argilés G, Saro J, Segal NH, Melero I, Ros W, Marabelle A, Rodriguez ME, Albanell J, Calvo E, Moreno V, Cleary JM, Eder P, Paz-Ares L, Hurwitz H, Bacac M, Perro M, Bouseida S, Sandoval F, Sabanes Bove D, Sreckovic S, Jamois C, Silva A, Klein C, Umana P, Karanikas V, Tabernero J. LBA-004Novel carcinoembryonic antigen T-cell bispecific (CEA-TCB) antibody: Preliminary clinical data as a single agent and in combination with atezolizumab in patients with metastatic colorectal cancer (mCRC). Ann Oncol. 2017 Jun 01; 28(suppl_3). PMID: 30052786.
    View in: PubMed
  6. Goyal L, Zheng H, Yurgelun MB, Abrams TA, Allen JN, Cleary JM, Knowles M, Regan E, Reardon A, Khachatryan A, Jain RK, Nardi V, Borger DR, Duda DG, Zhu AX. A phase 2 and biomarker study of cabozantinib in patients with advanced cholangiocarcinoma. Cancer. 2017 06 01; 123(11):1979-1988. PMID: 28192597.
    View in: PubMed
  7. Cleary JM, Rosen LS, Yoshida K, Rasco D, Shapiro GI, Sun W. A phase 1 study of the pharmacokinetics of nucleoside analog trifluridine and thymidine phosphorylase inhibitor tipiracil (components of TAS-102) vs trifluridine alone. Invest New Drugs. 2017 04; 35(2):189-197. PMID: 28111727.
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  8. Abramson VG, Supko JG, Ballinger T, Cleary JM, Hilton JF, Tolaney SM, Chau NG, Cho DC, Pearlberg J, Lager J, Shapiro GI, Arteaga CL. Phase Ib Study of Safety and Pharmacokinetics of the PI3K Inhibitor SAR245408 with the HER3-Neutralizing Human Antibody SAR256212 in Patients with Solid Tumors. Clin Cancer Res. 2017 Jul 15; 23(14):3520-3528. PMID: 28031425.
    View in: PubMed
  9. Sholl LM, Do K, Shivdasani P, Cerami E, Dubuc AM, Kuo FC, Garcia EP, Jia Y, Davineni P, Abo RP, Pugh TJ, van Hummelen P, Thorner AR, Ducar M, Berger AH, Nishino M, Janeway KA, Church A, Harris M, Ritterhouse LL, Campbell JD, Rojas-Rudilla V, Ligon AH, Ramkissoon S, Cleary JM, Matulonis U, Oxnard GR, Chao R, Tassell V, Christensen J, Hahn WC, Kantoff PW, Kwiatkowski DJ, Johnson BE, Meyerson M, Garraway LA, Shapiro GI, Rollins BJ, Lindeman NI, MacConaill LE. Institutional implementation of clinical tumor profiling on an unselected cancer population. JCI Insight. 2016 11 17; 1(19):e87062. PMID: 27882345.
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  10. Mouw KW, Cleary JM, Reardon B, Pike J, Braunstein LZ, Kim J, Amin-Mansour A, Miao D, Damish A, Chin J, Ott PA, Fuchs CS, Martin NE, Getz G, Carter S, Mamon HJ, Hornick JL, Van Allen EM, D'Andrea AD. Genomic Evolution after Chemoradiotherapy in Anal Squamous Cell Carcinoma. Clin Cancer Res. 2017 Jun 15; 23(12):3214-3222. PMID: 27852700.
    View in: PubMed
  11. Cleary JM, McRee AJ, Shapiro GI, Tolaney SM, O'Neil BH, Kearns JD, Mathews S, Nering R, MacBeath G, Czibere A, Sharma S, Korn WM. A phase 1 study combining the HER3 antibody seribantumab (MM-121) and cetuximab with and without irinotecan. Invest New Drugs. 2017 02; 35(1):68-78. PMID: 27853996.
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  12. Cleary JM, Mamon HJ, Szymonifka J, Bueno R, Choi N, Donahue DM, Fidias PM, Gaissert HA, Jaklitsch MT, Kulke MH, Lynch TP, Mentzer SJ, Meyerhardt JA, Swanson RS, Wain J, Fuchs CS, Enzinger PC. Neoadjuvant irinotecan, cisplatin, and concurrent radiation therapy with celecoxib for patients with locally advanced esophageal cancer. BMC Cancer. 2016 07 13; 16:468. PMID: 27412386; PMCID: PMC4944495.
  13. 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. 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. Clin Cancer Res. 2016 07 01; 22(13):3227-37. PMID: 26842236.
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  14. Sarantopoulos J, Shapiro GI, Cohen RB, Clark JW, Kauh JS, Weiss GJ, Cleary JM, Mahalingam D, Pickard MD, Faessel HM, Berger AJ, Burke K, Mulligan G, Dezube BJ, Harvey RD. Phase I Study of the Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (TAK-924/MLN4924) in Patients with Advanced Solid Tumors. Clin Cancer Res. 2016 Feb 15; 22(4):847-57. PMID: 26423795.
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  15. Jones SF, Siu LL, Bendell JC, Cleary JM, Razak AR, Infante JR, Pandya SS, Bedard PL, Pierce KJ, Houk B, Roberts WG, Shreeve SM, Shapiro GI. A phase I study of VS-6063, a second-generation focal adhesion kinase inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2015 10; 33(5):1100-7. PMID: 26334219.
    View in: PubMed
  16. Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14; 372(20):1909-19. PMID: 25970050.
    View in: PubMed
  17. Cleary JM, Reardon DA, Azad N, Gandhi L, Shapiro GI, Chaves J, Pedersen M, Ansell P, Ames W, Xiong H, Munasinghe W, Dudley M, Reilly EB, Holen K, Humerickhouse R. A phase 1 study of ABT-806 in subjects with advanced solid tumors. Invest New Drugs. 2015 Jun; 33(3):671-8. PMID: 25895099.
    View in: PubMed
  18. Tirumani SH, Kim KW, Nishino M, Howard SA, Krajewski KM, Jagannathan JP, Cleary JM, Ramaiya NH, Shinagare AB. Update on the role of imaging in management of metastatic colorectal cancer. Radiographics. 2014 Nov-Dec; 34(7):1908-28. PMID: 25384292; PMCID: PMC4386871.
  19. Messersmith WA, Shapiro GI, Cleary JM, Jimeno A, Dasari A, Huang B, Shaik MN, Cesari R, Zheng X, Reynolds JM, English PA, McLachlan KR, Kern KA, LoRusso PM. A Phase I, dose-finding study in patients with advanced solid malignancies of the oral ?-secretase inhibitor PF-03084014. Clin Cancer Res. 2015 Jan 01; 21(1):60-7. PMID: 25231399.
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  20. Cleary JM, Lima CM, Hurwitz HI, Montero AJ, Franklin C, Yang J, Graham A, Busman T, Mabry M, Holen K, Shapiro GI, Uronis H. A phase I clinical trial of navitoclax, a targeted high-affinity Bcl-2 family inhibitor, in combination with gemcitabine in patients with solid tumors. Invest New Drugs. 2014 Oct; 32(5):937-45. PMID: 24916770.
    View in: PubMed
  21. Wolpin BM, Rubinson DA, Wang X, Chan JA, Cleary JM, Enzinger PC, Fuchs CS, McCleary NJ, Meyerhardt JA, Ng K, Schrag D, Sikora AL, Spicer BA, Killion L, Mamon H, Kimmelman AC. Phase II and pharmacodynamic study of autophagy inhibition using hydroxychloroquine in patients with metastatic pancreatic adenocarcinoma. Oncologist. 2014 Jun; 19(6):637-8. PMID: 24821822; PMCID: PMC4041680.
  22. Wagle N, Grabiner BC, Van Allen EM, Hodis E, Jacobus S, Supko JG, Stewart M, Choueiri TK, Gandhi L, Cleary JM, Elfiky AA, Taplin ME, Stack EC, Signoretti S, Loda M, Shapiro GI, Sabatini DM, Lander ES, Gabriel SB, Kantoff PW, Garraway LA, Rosenberg JE. Activating mTOR mutations in a patient with an extraordinary response on a phase I trial of everolimus and pazopanib. Cancer Discov. 2014 May; 4(5):546-53. PMID: 24625776; PMCID: PMC4122326.
  23. Cleary JM, Rodig S, Barr PM, Shinagare AB, Clark JW, Shapiro GI, Armand P. Crizotinib as salvage and maintenance with allogeneic stem cell transplantation for refractory anaplastic large cell lymphoma. J Natl Compr Canc Netw. 2014 Mar 01; 12(3):323-6; quiz 326. PMID: 24616538.
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  24. Gandhi L, Bahleda R, Tolaney SM, Kwak EL, Cleary JM, Pandya SS, Hollebecque A, Abbas R, Ananthakrishnan R, Berkenblit A, Krygowski M, Liang Y, Turnbull KW, Shapiro GI, Soria JC. Phase I study of neratinib in combination with temsirolimus in patients with human epidermal growth factor receptor 2-dependent and other solid tumors. J Clin Oncol. 2014 Jan 10; 32(2):68-75. PMID: 24323026.
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  25. Howard SA, Krajewski KM, Thornton E, Jagannathan JP, O'Regan K, Cleary J, Ramaiya N. Decade of molecular targeted therapy: abdominal manifestations of drug toxicities--what radiologists should know. AJR Am J Roentgenol. 2012 Jul; 199(1):58-64. PMID: 22733894.
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  26. Thornton E, Howard SA, Jagannathan J, Krajewski KM, Shinagare AB, O'Regan K, Cleary JM, Ramaiya NH. Imaging features of bowel toxicities in the setting of molecular targeted therapies in cancer patients. Br J Radiol. 2012 Oct; 85(1018):1420-6. PMID: 22674709; PMCID: PMC3474016.
  27. Cho DC, Heath EI, Cleary JM, Kwak EL, Gandhi L, Lawrence DP, Zack C, Teofilovici F, Bradley R, Karol MD, Shapiro G, LoRusso P. A phase I dose-escalation study of the Hsp90 inhibitor ganetespib (STA-9090) administered twice weekly in patients with solid tumors: Updated report. J Clin Oncol. 2011 May 20; 29(15_suppl):3051. PMID: 28022585.
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  28. Jones SF, Shapiro G, Bendell JC, Chen EX, Bedard P, Cleary JM, Pandya S, Pierce KJ, Houk B, Hosea N, Zandi KS, Roberts WG, Shreeve SM, Siu LL. Phase I study of PF-04554878, a second-generation focal adhesion kinase (FAK) inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2011 May 20; 29(15_suppl):3002. PMID: 28022183.
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  29. Shapiro G, LoRusso P, Kwak EL, Cleary JM, Musib L, Jones C, de Crespigny A, Belvin M, McKenzie M, Gates MR, Chan IT, Bendell JC. Clinical combination of the MEK inhibitor GDC-0973 and the PI3K inhibitor GDC-0941: A first-in-human phase Ib study testing daily and intermittent dosing schedules in patients with advanced solid tumors. J Clin Oncol. 2011 May 20; 29(15_suppl):3005. PMID: 28022184.
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  30. Ho AL, Bendell JC, Cleary JM, Schwartz GK, Burris HA, Oakes P, Agbo F, Barker PN, Senderowicz AM, Shapiro G. Phase I, open-label, dose-escalation study of AZD7762 in combination with irinotecan (irino) in patients (pts) with advanced solid tumors. J Clin Oncol. 2011 May 20; 29(15_suppl):3033. PMID: 28022653.
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  31. Urban T, Sadow CA, Cleary JM, Harris GJ, Van Den Abbeele AD. Impact of RECIST 1.1 modifications on clinical trial eligibility. J Clin Oncol. 2011 May 20; 29(15_suppl):e16555. PMID: 28022052.
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  32. Ghamande SA, Lin C, Cho DC, Coleman TA, Chaudhary I, Cleary JM, Silverman MH, Kuo M, Mach W, Tseng Y, Hsu SC, Goel S. A phase I study of the novel DNA topoisomerase-1 inhibitor, TLC388, administered intravenously to patients with advanced solid tumors. J Clin Oncol. 2011 May 20; 29(15_suppl):e13618. PMID: 28023558.
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  33. Messersmith WA, LoRusso P, Cleary JM, Dasari A, Zhang X, Shaik MN, Courtney RD, Randolph S, Shapiro G. A phase I dose-escalation study of the novel gamma secretase inhibitor PF-03084014 in patients (pts) with advanced solid tumors. J Clin Oncol. 2011 May 20; 29(15_suppl):3100. PMID: 28022754.
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  34. Kauh JS, Shapiro G, Cohen RB, Clark JW, Harvey RD, Cleary JM, Mahalingam D, Kuan S, McDonald A, Berger A, Dezube B, Sarantopoulos J. MLN4924, an investigational NEDD8-activating enzyme (NAE) inhibitor, in patients (pts) with advanced solid tumors: Phase I study of multiple treatment schedules. J Clin Oncol. 2011 May 20; 29(15_suppl):3013. PMID: 28022162.
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  35. Cleary JM, Rocha Lima CM, Hurwitz H, Montero AJ, Shapiro G, Franklin C, Yang J, Graham AM, Busman T, Mabry M, Holen KD, Krivoshik A, Humerickhouse R, Uronis H. Combination study of navitoclax with gemcitabine (G) in patients (pts) with solid tumors. J Clin Oncol. 2011 May 20; 29(15_suppl):3067. PMID: 28022570.
    View in: PubMed
  36. Mita MM, Mita AC, Moseley J, Poon J, Small KA, Jou Y, Kirschmeier P, Zhang D, Statkevich P, Sankhala KK, Sarantopoulos J, Cleary JM, Chirieac LR, Rodig S, Bannerji R, Shapiro G. A phase I study of the CDK inhibitor dinaciclib (SCH 727965) administered every 3 weeks in patients (pts) with advanced malignancies: Final results. J Clin Oncol. 2011 May 20; 29(15_suppl):3080. PMID: 28022511.
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  37. Gandhi L, Bahleda R, Cleary JM, Hollebecque A, Kwak EL, Pandya S, Tolaney S, Abbas R, Ananthakrishnan R, Berkenblit A, Boni J, Clancy J, Turnbull KW, VoVan M, Shapiro G, Soria J. Two-dimensional phase I study of neratinib (NER) combined with temsirolimus (TEM) in patients (Pts) with solid tumors. J Clin Oncol. 2011 May 20; 29(15_suppl):3027. PMID: 28022681.
    View in: PubMed
  38. Zama IN, Hutson TE, Elson P, Cleary JM, Choueiri TK, Heng DY, Ramaiya N, Michaelson MD, Garcia JA, Knox JJ, Escudier B, Rini BI. Sunitinib rechallenge in metastatic renal cell carcinoma patients. Cancer. 2010 Dec 01; 116(23):5400-6. PMID: 21105118.
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  39. Cleary JM, Sadow PM, Randolph GW, Palmer EL, Lynch TP, Nikiforov YE, Wirth LJ. Neoadjuvant treatment of unresectable medullary thyroid cancer with sunitinib. J Clin Oncol. 2010 Aug 10; 28(23):e390-2. PMID: 20567012.
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  40. Cleary JM, Shapiro GI. Development of phosphoinositide-3 kinase pathway inhibitors for advanced cancer. Curr Oncol Rep. 2010 Mar; 12(2):87-94. PMID: 20425592.
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  41. Cleary JM, Tanabe KT, Lauwers GY, Zhu AX. Hepatic toxicities associated with the use of preoperative systemic therapy in patients with metastatic colorectal adenocarcinoma to the liver. Oncologist. 2009 Nov; 14(11):1095-105. PMID: 19880627.
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  42. Yowe D, Weich N, Prabhudas M, Poisson L, Errada P, Kapeller R, Yu K, Faron L, Shen M, Cleary J, Wilkie TM, Gutierrez-Ramos C, Hodge MR. RGS18 is a myeloerythroid lineage-specific regulator of G-protein-signalling molecule highly expressed in megakaryocytes. Biochem J. 2001 Oct 01; 359(Pt 1):109-18. PMID: 11563974; PMCID: PMC1222126.
  43. Farrar JT, Cleary J, Rauck R, Busch M, Nordbrock E. Oral transmucosal fentanyl citrate: randomized, double-blinded, placebo-controlled trial for treatment of breakthrough pain in cancer patients. J Natl Cancer Inst. 1998 Apr 15; 90(8):611-6. PMID: 9554444.
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  44. Berlin J, Tutsch KD, Hutson P, Cleary J, Rago RP, Arzoomanian RZ, Alberti D, Feierabend C, Wilding G. Phase I clinical and pharmacokinetic study of oral carboxyamidotriazole, a signal transduction inhibitor. J Clin Oncol. 1997 Feb; 15(2):781-9. PMID: 9053505.
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  45. Vartak NB, Lin CC, Cleary JM, Fagan MJ, Saier MH. Glucose metabolism in 'Sphingomonas elodea': pathway engineering via construction of a glucose-6-phosphate dehydrogenase insertion mutant. Microbiology. 1995 Sep; 141 ( Pt 9):2339-50. PMID: 7496544.
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  46. Hirano M, Cleary JM, Stewart AM, Lincoff NS, Odel JG, Santiesteban R, Santiago Luis R. Mitochondrial DNA mutations in an outbreak of optic neuropathy in Cuba. Neurology. 1994 May; 44(5):843-5. PMID: 8190285.
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  47. Harding NE, Raffo S, Raimondi A, Cleary JM, Ielpi L. Identification, genetic and biochemical analysis of genes involved in synthesis of sugar nucleotide precursors of xanthan gum. J Gen Microbiol. 1993 Mar; 139(3):447-57. PMID: 20050414.
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  48. Zyskind JW, Cleary JM, Brusilow WS, Harding NE, Smith DW. Chromosomal replication origin from the marine bacterium Vibrio harveyi functions in Escherichia coli: oriC consensus sequence. Proc Natl Acad Sci U S A. 1983 Mar; 80(5):1164-8. PMID: 6338499; PMCID: PMC393554.
  49. Harding NE, Cleary JM, Smith DW, Michon JJ, Brusilow WS, Zyskind JW. Chromosomal replication origins (oriC) of Enterobacter aerogenes and Klebsiella pneumoniae are functional in Escherichia coli. J Bacteriol. 1982 Dec; 152(3):983-93. PMID: 6292170; PMCID: PMC221601.
  50. Cleary JM, Smith DW, Harding NE, Zyskind JW. Primary structure of the chromosomal origins (oriC) of Enterobacter aerogenes and Klebsiella pneumoniae: comparisons and evolutionary relationships. J Bacteriol. 1982 Jun; 150(3):1467-71. PMID: 7042695; PMCID: PMC216374.
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Funded by the NIH/NCATS Clinical and Translational Science Award (CTSA) program, grant number UL1TR001102, and through institutional support from Harvard University, Harvard Medical School, Harvard T.H. Chan School of Public Health, Beth Israel Deaconess Medical Center, Boston Children's Hospital, Brigham and Women's Hospital, Massachusetts General Hospital and the Dana Farber Cancer Institute.