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Items: 36

1.

Correction: Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab.

Joseph RW, Elassaiss-Schaap J, Kefford R, Hwu WJ, Wolchok JD, Joshua AM, Ribas A, Hodi FS, Hamid O, Robert C, Daud A, Dronca R, Hersey P, Weber JS, Patnaik A, de Alwis DP, Perrone A, Zhang J, Kang SP, Ebbinghaus S, Anderson KM, Gangadhar TC.

Clin Cancer Res. 2018 Dec 1;24(23):6098. doi: 10.1158/1078-0432.CCR-18-3340. No abstract available.

PMID:
30510087
2.

Pembrolizumab KEYNOTE-001: an adaptive study leading to accelerated approval for two indications and a companion diagnostic.

Kang SP, Gergich K, Lubiniecki GM, de Alwis DP, Chen C, Tice MAB, Rubin EH.

Ann Oncol. 2017 Jun 1;28(6):1388-1398. doi: 10.1093/annonc/mdx076. No abstract available.

3.

Pembrolizumab Exposure-Response Assessments Challenged by Association of Cancer Cachexia and Catabolic Clearance.

Turner DC, Kondic AG, Anderson KM, Robinson AG, Garon EB, Riess JW, Jain L, Mayawala K, Kang J, Ebbinghaus SW, Sinha V, de Alwis DP, Stone JA.

Clin Cancer Res. 2018 Dec 1;24(23):5841-5849. doi: 10.1158/1078-0432.CCR-18-0415. Epub 2018 Jun 11.

PMID:
29891725
4.

Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab.

Joseph RW, Elassaiss-Schaap J, Kefford R, Hwu WJ, Wolchok JD, Joshua AM, Ribas A, Hodi FS, Hamid O, Robert C, Daud A, Dronca R, Hersey P, Weber JS, Patnaik A, de Alwis DP, Perrone A, Zhang J, Kang SP, Ebbinghaus S, Anderson KM, Gangadhar TC.

Clin Cancer Res. 2018 Oct 15;24(20):4960-4967. doi: 10.1158/1078-0432.CCR-17-2386. Epub 2018 Apr 23. Erratum in: Clin Cancer Res. 2018 Dec 1;24(23):6098.

PMID:
29685882
5.

Dose Finding Versus Speed in Seamless Immuno-Oncology Drug Development.

Mayawala K, Tse A, Rubin EH, Jain L, de Alwis DP.

J Clin Pharmacol. 2017 Oct;57 Suppl 10:S143-S145. doi: 10.1002/jcph.1001. No abstract available.

PMID:
28921649
6.

Population Pharmacokinetic/Pharmacodynamic Modeling of Tumor Size Dynamics in Pembrolizumab-Treated Advanced Melanoma.

Chatterjee MS, Elassaiss-Schaap J, Lindauer A, Turner DC, Sostelly A, Freshwater T, Mayawala K, Ahamadi M, Stone JA, de Greef R, Kondic AG, de Alwis DP.

CPT Pharmacometrics Syst Pharmacol. 2017 Jan;6(1):29-39. doi: 10.1002/psp4.12140. Epub 2016 Nov 29.

7.

Model-Based Characterization of the Pharmacokinetics of Pembrolizumab: A Humanized Anti-PD-1 Monoclonal Antibody in Advanced Solid Tumors.

Ahamadi M, Freshwater T, Prohn M, Li CH, de Alwis DP, de Greef R, Elassaiss-Schaap J, Kondic A, Stone JA.

CPT Pharmacometrics Syst Pharmacol. 2017 Jan;6(1):49-57. doi: 10.1002/psp4.12139. Epub 2016 Nov 14.

8.

Translational Pharmacokinetic/Pharmacodynamic Modeling of Tumor Growth Inhibition Supports Dose-Range Selection of the Anti-PD-1 Antibody Pembrolizumab.

Lindauer A, Valiathan CR, Mehta K, Sriram V, de Greef R, Elassaiss-Schaap J, de Alwis DP.

CPT Pharmacometrics Syst Pharmacol. 2017 Jan;6(1):11-20. doi: 10.1002/psp4.12130. Epub 2016 Nov 8.

9.

Using Model-Based "Learn and Confirm" to Reveal the Pharmacokinetics-Pharmacodynamics Relationship of Pembrolizumab in the KEYNOTE-001 Trial.

Elassaiss-Schaap J, Rossenu S, Lindauer A, Kang SP, de Greef R, Sachs JR, de Alwis DP.

CPT Pharmacometrics Syst Pharmacol. 2017 Jan;6(1):21-28. doi: 10.1002/psp4.12132. Epub 2016 Nov 8.

10.

Pembrolizumab: Role of Modeling and Simulation in Bringing a Novel Immunotherapy to Patients With Melanoma.

de Greef R, Elassaiss-Schaap J, Chatterjee M, Turner DC, Ahamadi M, Forman M, Cutler D, de Alwis DP, Kondic A, Stone J.

CPT Pharmacometrics Syst Pharmacol. 2017 Jan;6(1):5-7. doi: 10.1002/psp4.12131. Epub 2016 Nov 5. Review.

11.

Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy.

Nie L, Rubin EH, Mehrotra N, Pinheiro J, Fernandes LL, Roy A, Bailey S, de Alwis DP.

Clin Cancer Res. 2016 Jun 1;22(11):2623-9. doi: 10.1158/1078-0432.CCR-15-2644.

12.

Systematic evaluation of pembrolizumab dosing in patients with advanced non-small-cell lung cancer.

Chatterjee M, Turner DC, Felip E, Lena H, Cappuzzo F, Horn L, Garon EB, Hui R, Arkenau HT, Gubens MA, Hellmann MD, Dong D, Li C, Mayawala K, Freshwater T, Ahamadi M, Stone J, Lubiniecki GM, Zhang J, Im E, De Alwis DP, Kondic AG, Fløtten Ø.

Ann Oncol. 2016 Jul;27(7):1291-8. doi: 10.1093/annonc/mdw174. Epub 2016 Apr 26.

13.

Optimal Dosing for Targeted Therapies in Oncology: Drug Development Cases Leading by Example.

Sachs JR, Mayawala K, Gadamsetty S, Kang SP, de Alwis DP.

Clin Cancer Res. 2016 Mar 15;22(6):1318-24. doi: 10.1158/1078-0432.CCR-15-1295. Epub 2015 Nov 23. Review.

14.

Implementation of quantitative and systems pharmacology in large pharma.

Visser SA, de Alwis DP, Kerbusch T, Stone JA, Allerheiligen SR.

CPT Pharmacometrics Syst Pharmacol. 2014 Oct 22;3:e142. doi: 10.1038/psp.2014.40. Review.

15.

A phase I study of tasisulam sodium (LY573636 sodium), a novel anticancer compound, administered as a 24-h continuous infusion in patients with advanced solid tumors.

Gordon MS, Ilaria R Jr, de Alwis DP, Mendelson DS, McKane S, Wagner MM, Look KY, LoRusso PM.

Cancer Chemother Pharmacol. 2013 Jan;71(1):21-7. doi: 10.1007/s00280-012-1917-8. Epub 2012 Dec 11.

PMID:
23228983
16.

Tasisulam sodium (LY573636 sodium) as third-line treatment in patients with unresectable, metastatic non-small-cell lung cancer: a phase-II study.

Scagliotti GV, Ilaria R Jr, Novello S, von Pawel J, Fischer JR, Ermisch S, de Alwis DP, Andrews J, Reck M, Crino L, Eschbach C, Manegold C.

J Thorac Oncol. 2012 Jun;7(6):1053-7. doi: 10.1097/JTO.0b013e3182519d79.

17.

A phase II study of tasisulam sodium (LY573636 sodium) as second-line or third-line treatment for patients with unresectable or metastatic soft tissue sarcoma.

Ryan CW, Matias C, Agulnik M, Lopez-Pousa A, Williams C, de Alwis DP, Kaiser C, Miller MA, Ermisch S, Ilaria R Jr, Keohan ML.

Invest New Drugs. 2013 Feb;31(1):145-51. doi: 10.1007/s10637-012-9819-5. Epub 2012 Apr 27.

PMID:
22539091
18.

A phase 2 study of tasisulam sodium (LY573636 sodium) as second-line treatment for patients with unresectable or metastatic melanoma.

Kirkwood JM, Gonzalez R, Reintgen D, Clingan PR, McWilliams RR, de Alwis DP, Zimmermann A, Brown MP, Ilaria RL Jr, Millward MJ.

Cancer. 2011 Oct 15;117(20):4732-9. doi: 10.1002/cncr.26068. Epub 2011 Mar 31.

19.

A phase I study of tasisulam sodium (LY573636 sodium), a novel anticancer compound in patients with refractory solid tumors.

Simon GR, Ilaria RL Jr, Sovak MA, Williams CC, Haura EB, Cleverly AL, Sykes AK, Wagner MM, de Alwis DP, Slapak CA, Miller MA, Spriggs DR.

Cancer Chemother Pharmacol. 2011 Nov;68(5):1233-41. doi: 10.1007/s00280-011-1593-0. Epub 2011 Mar 23.

20.

Modelling the genesis and treatment of cancer: the potential role of physiologically based pharmacodynamics.

Steimer JL, Dahl SG, De Alwis DP, Gundert-Remy U, Karlsson MO, Martinkova J, Aarons L, Ahr HJ, Clairambault J, Freyer G, Friberg LE, Kern SE, Kopp-Schneider A, Ludwig WD, De Nicolao G, Rocchetti M, Troconiz IF.

Eur J Cancer. 2010 Jan;46(1):21-32. doi: 10.1016/j.ejca.2009.10.011.

PMID:
19954965
21.

The true face of the revolution in oncology drug development: a personal reflection.

Burgess M, de Alwis DP.

Curr Clin Pharmacol. 2007 Jan;2(1):31-5.

PMID:
18690853
22.

Semi-mechanistic modelling of the tumour growth inhibitory effects of LY2157299, a new type I receptor TGF-beta kinase antagonist, in mice.

Bueno L, de Alwis DP, Pitou C, Yingling J, Lahn M, Glatt S, Trocóniz IF.

Eur J Cancer. 2008 Jan;44(1):142-50. Epub 2007 Nov 26.

PMID:
18039567
23.

A phase I study of oral LY293111 given daily in combination with irinotecan in patients with solid tumours.

Baetz T, Eisenhauer E, Siu L, MacLean M, Doppler K, Walsh W, Fisher B, Khan AZ, de Alwis DP, Weitzman A, Brail LH, Moore M.

Invest New Drugs. 2007 Jun;25(3):217-25. Epub 2006 Dec 5.

PMID:
17146732
24.

Pharmacokinetics/Pharmacodynamics and the stages of drug development: role of modeling and simulation.

Chien JY, Friedrich S, Heathman MA, de Alwis DP, Sinha V.

AAPS J. 2005 Oct 7;7(3):E544-59. Review.

25.

Phase I and pharmacokinetic study of LY293111, an orally bioavailable LTB4 receptor antagonist, in patients with advanced solid tumors.

Schwartz GK, Weitzman A, O'Reilly E, Brail L, de Alwis DP, Cleverly A, Barile-Thiem B, Vinciguerra V, Budman DR.

J Clin Oncol. 2005 Aug 10;23(23):5365-73. Epub 2005 Jun 6.

PMID:
15939925
26.

Phase I study of the multidrug resistance inhibitor zosuquidar administered in combination with vinorelbine in patients with advanced solid tumours.

Lê LH, Moore MJ, Siu LL, Oza AM, MacLean M, Fisher B, Chaudhary A, de Alwis DP, Slapak C, Seymour L.

Cancer Chemother Pharmacol. 2005 Aug;56(2):154-60. Epub 2005 Apr 5.

PMID:
15809877
27.

Phase I study of docetaxel in combination with the P-glycoprotein inhibitor, zosuquidar, in resistant malignancies.

Fracasso PM, Goldstein LJ, de Alwis DP, Rader JS, Arquette MA, Goodner SA, Wright LP, Fears CL, Gazak RJ, Andre VA, Burgess MF, Slapak CA, Schellens JH.

Clin Cancer Res. 2004 Nov 1;10(21):7220-8.

28.

A Phase I trial of a potent P-glycoprotein inhibitor, zosuquidar trihydrochloride (LY335979), administered intravenously in combination with doxorubicin in patients with advanced malignancy.

Sandler A, Gordon M, De Alwis DP, Pouliquen I, Green L, Marder P, Chaudhary A, Fife K, Battiato L, Sweeney C, Jordan C, Burgess M, Slapak CA.

Clin Cancer Res. 2004 May 15;10(10):3265-72.

29.

Population pharmacokinetic model for daunorubicin and daunorubicinol coadministered with zosuquidar.3HCl (LY335979).

Callies S, de Alwis DP, Mehta A, Burgess M, Aarons L.

Cancer Chemother Pharmacol. 2004 Jul;54(1):39-48. Epub 2004 Mar 24.

PMID:
15045528
30.

A population pharmacokinetic model for paclitaxel in the presence of a novel P-gp modulator, Zosuquidar Trihydrochloride (LY335979).

Callies S, de Alwis DP, Harris A, Vasey P, Beijnen JH, Schellens JH, Burgess M, Aarons L.

Br J Clin Pharmacol. 2003 Jul;56(1):46-56. Erratum in: Br J Clin Pharmacol. 2003 Oct;56(4):463.

31.

A population pharmacokinetic model for doxorubicin and doxorubicinol in the presence of a novel MDR modulator, zosuquidar trihydrochloride (LY335979).

Callies S, de Alwis DP, Wright JG, Sandler A, Burgess M, Aarons L.

Cancer Chemother Pharmacol. 2003 Feb;51(2):107-18. Epub 2003 Jan 10.

PMID:
12647011
32.

Considerations in the design and development of transport inhibitors as adjuncts to drug therapy.

Dantzig AH, de Alwis DP, Burgess M.

Adv Drug Deliv Rev. 2003 Jan 21;55(1):133-50. Review.

PMID:
12535578
33.

A phase I trial of a potent P-glycoprotein inhibitor, Zosuquidar.3HCl trihydrochloride (LY335979), administered orally in combination with doxorubicin in patients with advanced malignancies.

Rubin EH, de Alwis DP, Pouliquen I, Green L, Marder P, Lin Y, Musanti R, Grospe SL, Smith SL, Toppmeyer DL, Much J, Kane M, Chaudhary A, Jordan C, Burgess M, Slapak CA.

Clin Cancer Res. 2002 Dec;8(12):3710-7.

34.

Comparison of manual versus ambulatory blood pressure measurements with pharmacokinetic-pharmacodynamic modeling of antihypertensive compounds: application to moxonidine.

Trocóniz IF, de Alwis DP, Tillmann C, Callies S, Mitchell M, Schaefer HG.

Clin Pharmacol Ther. 2000 Jul;68(1):18-27.

PMID:
10945312
35.

Population pharmacokinetic-pharmacodynamic modeling of moxonidine using 24-hour ambulatory blood pressure measurements.

Hempel G, Karlsson MO, de Alwis DP, Toublanc N, McNay J, Schaefer HG.

Clin Pharmacol Ther. 1998 Dec;64(6):622-35.

PMID:
9871427
36.

Population pharmacokinetics of ondansetron: a covariate analysis.

de Alwis DP, Aarons L, Palmer JL.

Br J Clin Pharmacol. 1998 Aug;46(2):117-25.

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