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Items: 21


Leveraging historical data into oncology development programs: Two case studies of phase 2 Bayesian augmented control trial designs.

Smith CL, Thomas Z, Enas N, Thorn K, Lahn M, Benhadji K, Cleverly A.

Pharm Stat. 2020 Jan 5. doi: 10.1002/pst.1990. [Epub ahead of print]


Early change in tumour size predicts overall survival in patients with first-line metastatic breast cancer.

Tate SC, Andre V, Enas N, Ribba B, Gueorguieva I.

Eur J Cancer. 2016 Oct;66:95-103. doi: 10.1016/j.ejca.2016.07.009. Epub 2016 Aug 18.


Models for change in tumour size, appearance of new lesions and survival probability in patients with advanced epithelial ovarian cancer.

Zecchin C, Gueorguieva I, Enas NH, Friberg LE.

Br J Clin Pharmacol. 2016 Sep;82(3):717-27. doi: 10.1111/bcp.12994. Epub 2016 Jun 8.


Phase 1/2 study of ocaratuzumab, an Fc-engineered humanized anti-CD20 monoclonal antibody, in low-affinity FcγRIIIa patients with previously treated follicular lymphoma.

Ganjoo KN, de Vos S, Pohlman BL, Flinn IW, Forero-Torres A, Enas NH, Cronier DM, Dang NH, Foon KA, Carpenter SP, Slapak CA, Link BK, Smith MR, Mapara MY, Wooldridge JE.

Leuk Lymphoma. 2015 Jan;56(1):42-8. doi: 10.3109/10428194.2014.911859. Epub 2014 Jul 14.


Randomized, double-blind, phase II trial comparing gemcitabine-cisplatin plus the LTB4 antagonist LY293111 versus gemcitabine-cisplatin plus placebo in first-line non-small-cell lung cancer.

Jänne PA, Paz-Ares L, Oh Y, Eschbach C, Hirsh V, Enas N, Brail L, von Pawel J.

J Thorac Oncol. 2014 Jan;9(1):126-31. doi: 10.1097/JTO.0000000000000037.


Use of historical control data for assessing treatment effects in clinical trials.

Viele K, Berry S, Neuenschwander B, Amzal B, Chen F, Enas N, Hobbs B, Ibrahim JG, Kinnersley N, Lindborg S, Micallef S, Roychoudhury S, Thompson L.

Pharm Stat. 2014 Jan-Feb;13(1):41-54. doi: 10.1002/pst.1589. Epub 2013 Aug 5. Review.


Randomization by minimization for unbalanced treatment allocation.

Han B, Enas NH, McEntegart D.

Stat Med. 2009 Nov 30;28(27):3329-46. doi: 10.1002/sim.3710.


Randomized double-blind phase II trial comparing gemcitabine plus LY293111 versus gemcitabine plus placebo in advanced adenocarcinoma of the pancreas.

Saif MW, Oettle H, Vervenne WL, Thomas JP, Spitzer G, Visseren-Grul C, Enas N, Richards DA.

Cancer J. 2009 Jul-Aug;15(4):339-43. doi: 10.1097/PPO.0b013e3181b36264.


In Vivo Measurements of Tumor Metabolism and Growth after Administration of Enzastaurin Using Small Animal FDG Positron Emission Tomography.

Pollok KE, Lahn M, Enas N, McNulty A, Graff J, Cai S, Hartwell JR, Ernstberger A, Thornton D, Brail L, Hutchins G.

J Oncol. 2009;2009:596560. doi: 10.1155/2009/596560. Epub 2009 May 27.


Phase I pharmacokinetic and pharmacodynamic study of the oral protein kinase C beta-inhibitor enzastaurin in combination with gemcitabine and cisplatin in patients with advanced cancer.

Rademaker-Lakhai JM, Beerepoot LV, Mehra N, Radema SA, van Maanen R, Vermaat JS, Witteveen EO, Visseren-Grul CM, Musib L, Enas N, van Hal G, Beijnen JH, Schellens JH, Voest EE.

Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4474-81.


Phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory diffuse large B-cell lymphoma.

Robertson MJ, Kahl BS, Vose JM, de Vos S, Laughlin M, Flynn PJ, Rowland K, Cruz JC, Goldberg SL, Musib L, Darstein C, Enas N, Kutok JL, Aster JC, Neuberg D, Savage KJ, LaCasce A, Thornton D, Slapak CA, Shipp MA.

J Clin Oncol. 2007 May 1;25(13):1741-6. Epub 2007 Mar 26.


Phase I dose escalation and pharmacokinetic study of enzastaurin, an oral protein kinase C beta inhibitor, in patients with advanced cancer.

Carducci MA, Musib L, Kies MS, Pili R, Truong M, Brahmer JR, Cole P, Sullivan R, Riddle J, Schmidt J, Enas N, Sinha V, Thornton DE, Herbst RS.

J Clin Oncol. 2006 Sep 1;24(25):4092-9.


Randomized phase II studies and their ethics.

Abratt RP, Reece WH, Enas NH, Stephens R.

J Clin Oncol. 2005 Dec 20;23(36):9443. No abstract available.


Randomized, double-blind, multicenter trial comparing two doses of arzoxifene (LY353381) in hormone-sensitive advanced or metastatic breast cancer patients.

Baselga J, Llombart-Cussac A, Bellet M, Guillem-Porta V, Enas N, Krejcy K, Carrasco E, Kayitalire L, Kuta M, Lluch A, Vodvarka P, Kerbrat P, Namer M, Petruzelka L.

Ann Oncol. 2003 Sep;14(9):1383-90.


Phase I trial of the cryptophycin analogue LY355703 administered as an intravenous infusion on a day 1 and 8 schedule every 21 days.

Stevenson JP, Sun W, Gallagher M, Johnson R, Vaughn D, Schuchter L, Algazy K, Hahn S, Enas N, Ellis D, Thornton D, O'Dwyer PJ.

Clin Cancer Res. 2002 Aug;8(8):2524-9.


Phase I study of a third-generation selective estrogen receptor modulator, LY353381.HCL, in metastatic breast cancer.

Münster PN, Buzdar A, Dhingra K, Enas N, Ni L, Major M, Melemed A, Seidman A, Booser D, Theriault R, Norton L, Hudis C.

J Clin Oncol. 2001 Apr 1;19(7):2002-9.


An investigational new drug treatment program for patients with gemcitabine: results for over 3000 patients with pancreatic carcinoma.

Storniolo AM, Enas NH, Brown CA, Voi M, Rothenberg ML, Schilsky R.

Cancer. 1999 Mar 15;85(6):1261-8.


Nizatidine prevents peptic ulceration in high-risk patients taking nonsteroidal anti-inflammatory drugs.

Levine LR, Cloud ML, Enas NH.

Arch Intern Med. 1993 Nov 8;153(21):2449-54.


Sensitivity and specificity of tests: can the "silent majority" speak?

Tavel ME, Enas NH, Woods JR.

Am J Cardiol. 1987 Nov 15;60(14):1167-9. No abstract available.


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