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Improving attribution of adverse events in oncology clinical trials.

George GC, Barata PC, Campbell A, Chen A, Cortes JE, Hyman DM, Jones L, Karagiannis T, Klaar S, Le-Rademacher JG, LoRusso P, Mandrekar SJ, Merino DM, Minasian LM, Mitchell SA, Montez S, O'Connor DJ, Pettit S, Silk E, Sloan JA, Stewart M, Takimoto CH, Wong GY, Yap TA, Cleeland CS, Hong DS.

Cancer Treat Rev. 2019 Jun;76:33-40. doi: 10.1016/j.ctrv.2019.04.004. Epub 2019 Apr 25. Review.


First-in-Human, First-in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With Advanced Cancers.

Sikic BI, Lakhani N, Patnaik A, Shah SA, Chandana SR, Rasco D, Colevas AD, O'Rourke T, Narayanan S, Papadopoulos K, Fisher GA, Villalobos V, Prohaska SS, Howard M, Beeram M, Chao MP, Agoram B, Chen JY, Huang J, Axt M, Liu J, Volkmer JP, Majeti R, Weissman IL, Takimoto CH, Supan D, Wakelee HA, Aoki R, Pegram MD, Padda SK.

J Clin Oncol. 2019 Apr 20;37(12):946-953. doi: 10.1200/JCO.18.02018. Epub 2019 Feb 27.


The Macrophage 'Do not eat me' signal, CD47, is a clinically validated cancer immunotherapy target.

Takimoto CH, Chao MP, Gibbs C, McCamish MA, Liu J, Chen JY, Majeti R, Weissman IL.

Ann Oncol. 2019 Mar 1;30(3):486-489. doi: 10.1093/annonc/mdz006. No abstract available.


CD47 Blockade by Hu5F9-G4 and Rituximab in Non-Hodgkin's Lymphoma.

Advani R, Flinn I, Popplewell L, Forero A, Bartlett NL, Ghosh N, Kline J, Roschewski M, LaCasce A, Collins GP, Tran T, Lynn J, Chen JY, Volkmer JP, Agoram B, Huang J, Majeti R, Weissman IL, Takimoto CH, Chao MP, Smith SM.

N Engl J Med. 2018 Nov 1;379(18):1711-1721. doi: 10.1056/NEJMoa1807315.


Two phase I, pharmacokinetic, and pharmacodynamic studies of DFP-10917, a novel nucleoside analog with 14-day and 7-day continuous infusion schedules.

Sankhala K, Takimoto CH, Mita AC, Xiong H, Rodón J, Mehrvarz Sarshekeh A, Burns K, Iizuka K, Kopetz S.

Invest New Drugs. 2019 Feb;37(1):76-86. doi: 10.1007/s10637-018-0602-0. Epub 2018 Apr 18.


Population pharmacokinetic analysis of oxaliplatin in adults and children identifies important covariates for dosing.

Nikanjam M, Stewart CF, Takimoto CH, Synold TW, Beaty O, Fouladi M, Capparelli EV.

Cancer Chemother Pharmacol. 2015 Mar;75(3):495-503. doi: 10.1007/s00280-014-2667-6. Epub 2015 Jan 4.


Translation of anticancer efficacy from nonclinical models to the clinic.

Stroh M, Duda DG, Takimoto CH, Yamazaki S, Vicini P.

CPT Pharmacometrics Syst Pharmacol. 2014 Aug 6;3:e128. doi: 10.1038/psp.2014.28.


Using pharmacokinetic and pharmacodynamic data in early decision making regarding drug development: a phase I clinical trial evaluating tyrosine kinase inhibitor, AEE788.

Baselga J, Mita AC, Schöffski P, Dumez H, Rojo F, Tabernero J, DiLea C, Mietlowski W, Low C, Huang J, Dugan M, Parker K, Walk E, van Oosterom A, Martinelli E, Takimoto CH.

Clin Cancer Res. 2012 Nov 15;18(22):6364-72. doi: 10.1158/1078-0432.CCR-12-1499. Epub 2012 Sep 26.


Pharmacokinetics and safety of bortezomib in patients with advanced malignancies and varying degrees of liver dysfunction: phase I NCI Organ Dysfunction Working Group Study NCI-6432.

LoRusso PM, Venkatakrishnan K, Ramanathan RK, Sarantopoulos J, Mulkerin D, Shibata SI, Hamilton A, Dowlati A, Mani S, Rudek MA, Takimoto CH, Neuwirth R, Esseltine DL, Ivy P.

Clin Cancer Res. 2012 May 15;18(10):2954-63. doi: 10.1158/1078-0432.CCR-11-2873. Epub 2012 Mar 6.


The effect of bexarotene on atorvastatin pharmacokinetics: results from a phase I trial of bexarotene plus chemotherapy in patients with advanced non-small cell lung cancer.

Wakelee HA, Takimoto CH, Lopez-Anaya A, Chu Q, Middleton G, Dunlop D, Ramlau R, Leighl N, Rowinsky EK, Hao D, Zatloukal P, Jacobs CD, Rodon J.

Cancer Chemother Pharmacol. 2012 Feb;69(2):563-71. doi: 10.1007/s00280-011-1772-z. Epub 2011 Nov 6.


A phase I pharmacokinetic study of bexarotene with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer (NSCLC).

Rodon J, Jacobs CD, Chu Q, Rowinsky EK, Lopez-Anaya A, Takimoto CH, Wakelee HA.

Cancer Chemother Pharmacol. 2012 Mar;69(3):825-34. doi: 10.1007/s00280-011-1770-1. Epub 2011 Nov 6.


Heat shock proteins: a potential anticancer target.

Sankhala KK, Mita MM, Mita AC, Takimoto CH.

Curr Drug Targets. 2011 Dec;12(14):2001-8. Review.


Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study.

Leal TB, Remick SC, Takimoto CH, Ramanathan RK, Davies A, Egorin MJ, Hamilton A, LoRusso PA, Shibata S, Lenz HJ, Mier J, Sarantopoulos J, Mani S, Wright JJ, Ivy SP, Neuwirth R, von Moltke L, Venkatakrishnan K, Mulkerin D.

Cancer Chemother Pharmacol. 2011 Dec;68(6):1439-47. doi: 10.1007/s00280-011-1637-5. Epub 2011 Apr 9.


Effects of patupilone on the pharmacokinetics and pharmacodynamics of warfarin in patients with advanced malignancies: a phase I clinical trial.

Tsimberidou AM, Takimoto CH, Moulder S, Uehara C, Mita M, Mita A, Urban P, Tan E, Wang Y, Vining D, Kurzrock R.

Mol Cancer Ther. 2011 Jan;10(1):209-17. doi: 10.1158/1535-7163.MCT-10-0774.


Mechanism-based pharmacokinetic/pharmacodynamic model for troxacitabine-induced neutropenia in cancer patients.

Ng CM, Patnaik A, Beeram M, Lin CC, Takimoto CH.

Cancer Chemother Pharmacol. 2011 May;67(5):985-94. doi: 10.1007/s00280-010-1393-y. Epub 2010 Jul 8.


Phase 1 study of AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adults with advanced solid tumors.

Mita AC, Takimoto CH, Mita M, Tolcher A, Sankhala K, Sarantopoulos J, Valdivieso M, Wood L, Rasmussen E, Sun YN, Zhong ZD, Bass MB, Le N, LoRusso P.

Clin Cancer Res. 2010 Jun 1;16(11):3044-56. doi: 10.1158/1078-0432.CCR-09-3368. Epub 2010 May 25.


Pharmacokinetics and pharmacodynamic biomarkers in early oncology drug development.

Takimoto CH.

Eur J Cancer. 2009 Sep;45 Suppl 1:436-8. doi: 10.1016/S0959-8049(09)70080-2. No abstract available.


A phase I study of eribulin mesylate (E7389), a mechanistically novel inhibitor of microtubule dynamics, in patients with advanced solid malignancies.

Goel S, Mita AC, Mita M, Rowinsky EK, Chu QS, Wong N, Desjardins C, Fang F, Jansen M, Shuster DE, Mani S, Takimoto CH.

Clin Cancer Res. 2009 Jun 15;15(12):4207-12. doi: 10.1158/1078-0432.CCR-08-2429. Epub 2009 Jun 9.


Mechanism-based receptor-binding model to describe the pharmacokinetic and pharmacodynamic of an anti-α5β1 integrin monoclonal antibody (volociximab) in cancer patients.

Ng CM, Bai S, Takimoto CH, Tang MT, Tolcher AW.

Cancer Chemother Pharmacol. 2010 Jan;65(2):207-17. doi: 10.1007/s00280-009-1023-8.


Phase II study of sorafenib in patients with metastatic or recurrent sarcomas.

Maki RG, D'Adamo DR, Keohan ML, Saulle M, Schuetze SM, Undevia SD, Livingston MB, Cooney MM, Hensley ML, Mita MM, Takimoto CH, Kraft AS, Elias AD, Brockstein B, Blachère NE, Edgar MA, Schwartz LH, Qin LX, Antonescu CR, Schwartz GK.

J Clin Oncol. 2009 Jul 1;27(19):3133-40. doi: 10.1200/JCO.2008.20.4495. Epub 2009 May 18.


Phase I and pharmacokinetic study of cisplatin and troxacitabine administered intravenously every 28 days in patients with advanced solid malignancies.

Lin CC, Beeram M, Rowinsky EK, Takimoto CH, Ng CM, Geyer CE Jr, Denis LJ, De Bono JS, Hao D, Tolcher AW, Rha SY, Jolivet J, Patnaik A.

Cancer Chemother Pharmacol. 2009 Dec;65(1):167-75. doi: 10.1007/s00280-009-1020-y. Epub 2009 May 16.


Castration-resistant prostate cancer: locking up the molecular escape routes.

Attar RM, Takimoto CH, Gottardis MM.

Clin Cancer Res. 2009 May 15;15(10):3251-5. doi: 10.1158/1078-0432.CCR-08-1171. Epub 2009 May 15. Review.


Maximum tolerated dose: clinical endpoint for a bygone era?

Takimoto CH.

Target Oncol. 2009 Apr;4(2):143-7. doi: 10.1007/s11523-009-0108-y. Epub 2009 Apr 18. Review.


Population pharmacokinetic/pharmacodynamic analyses of pemetrexed and neutropenia: effect of vitamin supplementation and differences between Japanese and Western patients.

Latz JE, Schneck KL, Nakagawa K, Miller MA, Takimoto CH.

Clin Cancer Res. 2009 Jan 1;15(1):346-54. doi: 10.1158/1078-0432.CCR-08-0791.


Phase I study of paclitaxel poliglumex administered weekly for patients with advanced solid malignancies.

Mita M, Mita A, Sarantopoulos J, Takimoto CH, Rowinsky EK, Romero O, Angiuli P, Allievi C, Eisenfeld A, Verschraegen CF.

Cancer Chemother Pharmacol. 2009 Jul;64(2):287-95. doi: 10.1007/s00280-008-0869-5. Epub 2008 Nov 25.


Commentary: tumor growth, patient survival, and the search for the optimal phase II efficacy endpoint.

Takimoto CH.

Oncologist. 2008 Oct;13(10):1043-5. doi: 10.1634/theoncologist.2008-0180. Epub 2008 Oct 1. No abstract available.


Phase I study of cetuximab, erlotinib, and bevacizumab in patients with advanced solid tumors.

Lin CC, Calvo E, Papadopoulos KP, Patnaik A, Sarantopoulos J, Mita AC, Preston GG, Mita MM, Rodon J, Mays T, Yeh IT, O'Rourke P, Takimoto CH, Dancey JE, Chen H, Tolcher AW.

Cancer Chemother Pharmacol. 2009 May;63(6):1065-71. doi: 10.1007/s00280-008-0811-x. Epub 2008 Sep 16.


Phase 0 clinical trials in oncology: a paradigm shift for early drug development?

Takimoto CH.

Cancer Chemother Pharmacol. 2009 Mar;63(4):703-9. doi: 10.1007/s00280-008-0789-4. Epub 2008 Jul 10. Review.


Dietary genistein inhibits metastasis of human prostate cancer in mice.

Lakshman M, Xu L, Ananthanarayanan V, Cooper J, Takimoto CH, Helenowski I, Pelling JC, Bergan RC.

Cancer Res. 2008 Mar 15;68(6):2024-32. doi: 10.1158/0008-5472.CAN-07-1246.


Phase I and pharmacokinetic study of imatinib mesylate in patients with advanced malignancies and varying degrees of renal dysfunction: a study by the National Cancer Institute Organ Dysfunction Working Group.

Gibbons J, Egorin MJ, Ramanathan RK, Fu P, Mulkerin DL, Shibata S, Takimoto CH, Mani S, LoRusso PA, Grem JL, Pavlick A, Lenz HJ, Flick SM, Reynolds S, Lagattuta TF, Parise RA, Wang Y, Murgo AJ, Ivy SP, Remick SC; National Cancer Institute Organ Dysfunction Working Group.

J Clin Oncol. 2008 Feb 1;26(4):570-6. doi: 10.1200/JCO.2007.13.3819.


Phase I and pharmacokinetic study of imatinib mesylate in patients with advanced malignancies and varying degrees of liver dysfunction: a study by the National Cancer Institute Organ Dysfunction Working Group.

Ramanathan RK, Egorin MJ, Takimoto CH, Remick SC, Doroshow JH, LoRusso PA, Mulkerin DL, Grem JL, Hamilton A, Murgo AJ, Potter DM, Belani CP, Hayes MJ, Peng B, Ivy SP; National Cancer Institute Organ Dysfunction Working Group.

J Clin Oncol. 2008 Feb 1;26(4):563-9. doi: 10.1200/JCO.2007.11.0304.


Safety and anti-tumor activity of sorafenib (Nexavar) in combination with other anti-cancer agents: a review of clinical trials.

Takimoto CH, Awada A.

Cancer Chemother Pharmacol. 2008 Apr;61(4):535-48. Epub 2007 Nov 17. Review.


Oxaliplatin pharmacokinetics and pharmacodynamics in adult cancer patients with impaired renal function.

Takimoto CH, Graham MA, Lockwood G, Ng CM, Goetz A, Greenslade D, Remick SC, Sharma S, Mani S, Ramanathan RK, Synold TW, Doroshow JH, Hamilton A, Mulkerin DL, Ivy P, Egorin MJ, Grem JL.

Clin Cancer Res. 2007 Aug 15;13(16):4832-9.


Expression of epiregulin and amphiregulin and K-ras mutation status predict disease control in metastatic colorectal cancer patients treated with cetuximab.

Khambata-Ford S, Garrett CR, Meropol NJ, Basik M, Harbison CT, Wu S, Wong TW, Huang X, Takimoto CH, Godwin AK, Tan BR, Krishnamurthi SS, Burris HA 3rd, Poplin EA, Hidalgo M, Baselga J, Clark EA, Mauro DJ.

J Clin Oncol. 2007 Aug 1;25(22):3230-7.


Dose-escalating and pharmacologic study of oxaliplatin in adult cancer patients with impaired hepatic function: a National Cancer Institute Organ Dysfunction Working Group study.

Synold TW, Takimoto CH, Doroshow JH, Gandara D, Mani S, Remick SC, Mulkerin DL, Hamilton A, Sharma S, Ramanathan RK, Lenz HJ, Graham M, Longmate J, Kaufman BM, Ivy P; National Cancer Institute Organ Dysfunction Working Group.

Clin Cancer Res. 2007 Jun 15;13(12):3660-6.


Phase I and pharmacokinetic study of pemetrexed with high-dose folic acid supplementation or multivitamin supplementation in patients with locally advanced or metastatic cancer.

Takimoto CH, Hammond-Thelin LA, Latz JE, Forero L, Beeram M, Forouzesh B, de Bono J, Tolcher AW, Patnaik A, Monroe P, Wood L, Schneck KB, Clark R, Rowinsky EK.

Clin Cancer Res. 2007 May 1;13(9):2675-83.


Can tamoxifen therapy be optimized for patients with breast cancer on the basis of CYP2D6 activity assessments?

Takimoto CH.

Nat Clin Pract Oncol. 2007 Mar;4(3):152-3. Epub 2007 Jan 23. No abstract available.


Design, conduct, and interpretation of organ impairment studies in oncology patients.

Takimoto CH, Mita AC.

J Clin Oncol. 2006 Jul 20;24(21):3509-10; author reply 3510-1. No abstract available.


Chronomodulated chemotherapy for colorectal cancer: failing the test of time?

Takimoto CH.

Eur J Cancer. 2006 Mar;42(5):574-81. Epub 2006 Jan 24. Review. No abstract available.


Two drug interaction studies evaluating the pharmacokinetics and toxicity of pemetrexed when coadministered with aspirin or Ibuprofen in patients with advanced cancer.

Sweeney CJ, Takimoto CH, Latz JE, Baker SD, Murry DJ, Krull JH, Fife K, Battiato L, Cleverly A, Chaudhary AK, Chaudhuri T, Sandler A, Mita AC, Rowinsky EK.

Clin Cancer Res. 2006 Jan 15;12(2):536-42.


Phase I trial of sorafenib and gemcitabine in advanced solid tumors with an expanded cohort in advanced pancreatic cancer.

Siu LL, Awada A, Takimoto CH, Piccart M, Schwartz B, Giannaris T, Lathia C, Petrenciuc O, Moore MJ.

Clin Cancer Res. 2006 Jan 1;12(1):144-51.


Phase I and pharmacokinetic study of pemetrexed administered every 3 weeks to advanced cancer patients with normal and impaired renal function.

Mita AC, Sweeney CJ, Baker SD, Goetz A, Hammond LA, Patnaik A, Tolcher AW, Villalona-Calero M, Sandler A, Chaudhuri T, Molpus K, Latz JE, Simms L, Chaudhary AK, Johnson RD, Rowinsky EK, Takimoto CH.

J Clin Oncol. 2006 Feb 1;24(4):552-62. Epub 2006 Jan 3.


Phase I and pharmacokinetic study of sequences of the rebeccamycin analogue NSC 655649 and cisplatin in patients with advanced solid tumors.

Ricart AD, Hammond LA, Kuhn JG, Takimoto CH, Goetz A, Forouzesh B, Forero L, Ochoa-Bayona JL, Berg K, Tolcher AW, Rowinsky EK.

Clin Cancer Res. 2005 Dec 15;11(24 Pt 1):8728-36.


Phase 1 study of weekly polyethylene glycol-camptothecin in patients with advanced solid tumors and lymphomas.

Posey JA 3rd, Saif MW, Carlisle R, Goetz A, Rizzo J, Stevenson S, Rudoltz MS, Kwiatek J, Simmons P, Rowinsky EK, Takimoto CH, Tolcher AW.

Clin Cancer Res. 2005 Nov 1;11(21):7866-71.


Can docetaxel dosing be individualized based on cytochrome p450 activity?

Takimoto CH.

Nat Clin Pract Oncol. 2005 Sep;2(9):446-7. No abstract available.


Are there any better camptothecins than the ones we have?

Takimoto CH.

Clin Adv Hematol Oncol. 2003 Oct;1(10):578-9, 600. No abstract available.


Thymidylate synthase inhibitors.

Takimoto CH, Diggikar S.

Cancer Chemother Biol Response Modif. 2005;22:1-18. Review. No abstract available.


Phase I and pharmacologic study of 17-(allylamino)-17-demethoxygeldanamycin in adult patients with solid tumors.

Grem JL, Morrison G, Guo XD, Agnew E, Takimoto CH, Thomas R, Szabo E, Grochow L, Grollman F, Hamilton JM, Neckers L, Wilson RH.

J Clin Oncol. 2005 Mar 20;23(9):1885-93.


Doege-Potter syndrome: hypoglycemia associated with malignant solitary fibrous tumor.

Zafar H, Takimoto CH, Weiss G.

Med Oncol. 2003;20(4):403-8. Review.


A phase I and pharmacokinetic study of ILX-295501, an oral diarylsulfonylurea, on a weekly for 3 weeks every 4-week schedule in patients with advanced solid malignancies.

Forouzesh B, Takimoto CH, Goetz A, Diab S, Hammond LA, Smetzer L, Schwartz G, Gazak R, Callaghan JT, Von Hoff DD, Rowinsky EK.

Clin Cancer Res. 2003 Nov 15;9(15):5540-9.

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