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Items: 45


Tumor-targeted 4-1BB agonists for combination with T cell bispecific antibodies as off-the-shelf therapy.

Claus C, Ferrara C, Xu W, Sam J, Lang S, Uhlenbrock F, Albrecht R, Herter S, Schlenker R, Hüsser T, Diggelmann S, Challier J, Mössner E, Hosse RJ, Hofer T, Brünker P, Joseph C, Benz J, Ringler P, Stahlberg H, Lauer M, Perro M, Chen S, Küttel C, Bhavani Mohan PL, Nicolini V, Birk MC, Ongaro A, Prince C, Gianotti R, Dugan G, Whitlow CT, Solingapuram Sai KK, Caudell DL, Burgos-Rodriguez AG, Cline JM, Hettich M, Ceppi M, Giusti AM, Crameri F, Driessen W, Morcos PN, Freimoser-Grundschober A, Levitsky V, Amann M, Grau-Richards S, von Hirschheydt T, Tournaviti S, Mølhøj M, Fauti T, Heinzelmann-Schwarz V, Teichgräber V, Colombetti S, Bacac M, Zippelius A, Klein C, Umaña P.

Sci Transl Med. 2019 Jun 12;11(496). pii: eaav5989. doi: 10.1126/scitranslmed.aav5989.


Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALESIA): a randomised phase 3 study.

Zhou C, Kim SW, Reungwetwattana T, Zhou J, Zhang Y, He J, Yang JJ, Cheng Y, Lee SH, Bu L, Xu T, Yang L, Wang C, Liu T, Morcos PN, Lu Y, Zhang L.

Lancet Respir Med. 2019 May;7(5):437-446. doi: 10.1016/S2213-2600(19)30053-0. Epub 2019 Apr 10.


Rituximab dosing in hematological malignancies: an old question, revisited.

Morcos PN, Boehnke A, Valente N, Mager DE.

Cancer Chemother Pharmacol. 2019 Sep;84(3):661-666. doi: 10.1007/s00280-019-03818-1. Epub 2019 Mar 21.


Model-Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First-Line Anaplastic Lymphoma Kinase + Non-Small Cell Lung Cancer.

Morcos PN, Liu J, Blumenthal GM, Zhao H.

Clin Pharmacol Ther. 2019 Apr;105(4):826-828. doi: 10.1002/cpt.1340. Epub 2019 Feb 5. No abstract available.


Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib.

Morcos PN, Cleary Y, Sturm-Pellanda C, Guerini E, Abt M, Donzelli M, Vazvaei F, Balas B, Parrott N, Yu L.

J Clin Pharmacol. 2018 Dec;58(12):1618-1628. doi: 10.1002/jcph.1286. Epub 2018 Jul 27.


Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer.

Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F.

Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10.


Model-Based Assessments of CYP-Mediated Drug-Drug Interaction Risk of Alectinib: Physiologically Based Pharmacokinetic Modeling Supported Clinical Development.

Cleary Y, Gertz M, Morcos PN, Yu L, Youdim K, Phipps A, Fowler S, Parrott N.

Clin Pharmacol Ther. 2018 Sep;104(3):505-514. doi: 10.1002/cpt.956. Epub 2017 Dec 27.


Metabolites of alectinib in human: their identification and pharmacological activity.

Sato-Nakai M, Kawashima K, Nakagawa T, Tachibana Y, Yoshida M, Takanashi K, Morcos PN, Binder M, Moore DJ, Yu L.

Heliyon. 2017 Jul 10;3(7):e00354. doi: 10.1016/j.heliyon.2017.e00354. eCollection 2017 Jul.


Pooled Systemic Efficacy and Safety Data from the Pivotal Phase II Studies (NP28673 and NP28761) of Alectinib in ALK-positive Non-Small Cell Lung Cancer.

Yang JC, Ou SI, De Petris L, Gadgeel S, Gandhi L, Kim DW, Barlesi F, Govindan R, Dingemans AC, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Golding S, Bordogna W, Balas B, Morcos PN, Zeaiter A, Shaw AT.

J Thorac Oncol. 2017 Oct;12(10):1552-1560. doi: 10.1016/j.jtho.2017.06.070. Epub 2017 Jul 6.


Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer.

Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Pérol M, Dziadziuszko R, Rosell R, Zeaiter A, Mitry E, Golding S, Balas B, Noe J, Morcos PN, Mok T; ALEX Trial Investigators.

N Engl J Med. 2017 Aug 31;377(9):829-838. doi: 10.1056/NEJMoa1704795. Epub 2017 Jun 6.


Progress in Prediction and Interpretation of Clinically Relevant Metabolic Drug-Drug Interactions: a Minireview Illustrating Recent Developments and Current Opportunities.

Fowler S, Morcos PN, Cleary Y, Martin-Facklam M, Parrott N, Gertz M, Yu L.

Curr Pharmacol Rep. 2017;3(1):36-49. doi: 10.1007/s40495-017-0082-5. Epub 2017 Feb 1. Review.


Effect of alectinib on cardiac electrophysiology: results from intensive electrocardiogram monitoring from the pivotal phase II NP28761 and NP28673 studies.

Morcos PN, Bogman K, Hubeaux S, Sturm-Pellanda C, Ruf T, Bordogna W, Golding S, Zeaiter A, Abt M, Balas B.

Cancer Chemother Pharmacol. 2017 Mar;79(3):559-568. doi: 10.1007/s00280-017-3253-5. Epub 2017 Feb 27.


LC-MS/MS determination of alectinib and its major human metabolite M4 in human urine: prevention of nonspecific binding.

Heinig K, Herzog D, Ferrari L, Fraier D, Miya K, Morcos PN.

Bioanalysis. 2017 Mar;9(5):459-468. doi: 10.4155/bio-2016-0284. Epub 2017 Feb 8.


Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib.

Parrott NJ, Yu LJ, Takano R, Nakamura M, Morcos PN.

AAPS J. 2016 Nov;18(6):1464-1474. Epub 2016 Jul 22.


Effect of the Wetting Agent Sodium Lauryl Sulfate on the Pharmacokinetics of Alectinib: Results From a Bioequivalence Study in Healthy Subjects.

Morcos PN, Parrott N, Banken L, Timpe C, Lindenberg M, Guerini E, Dall G, Bogman K, Sturm C, Zeaiter A, Martin-Facklam M, Phipps A.

Clin Pharmacol Drug Dev. 2017 May;6(3):266-279. doi: 10.1002/cpdd.299. Epub 2016 Oct 3.


Clinical Drug-Drug Interactions Through Cytochrome P450 3A (CYP3A) for the Selective ALK Inhibitor Alectinib.

Morcos PN, Cleary Y, Guerini E, Dall G, Bogman K, De Petris L, Viteri S, Bordogna W, Yu L, Martin-Facklam M, Phipps A.

Clin Pharmacol Drug Dev. 2017 May;6(3):280-291. doi: 10.1002/cpdd.298. Epub 2016 Sep 28.


Effect of Food and Esomeprazole on the Pharmacokinetics of Alectinib, a Highly Selective ALK Inhibitor, in Healthy Subjects.

Morcos PN, Guerini E, Parrott N, Dall G, Blotner S, Bogman K, Sturm C, Balas B, Martin-Facklam M, Phipps A.

Clin Pharmacol Drug Dev. 2017 Jul;6(4):388-397. doi: 10.1002/cpdd.296. Epub 2016 Sep 28.


Bioanalysis of alectinib and metabolite M4 in human plasma, cross-validation and impact on PK assessment.

Heinig K, Miya K, Kamei T, Guerini E, Fraier D, Yu L, Bansal S, Morcos PN.

Bioanalysis. 2016 Jul;8(14):1465-79. doi: 10.4155/bio-2016-0068. Epub 2016 Jun 22.


Absorption, distribution, metabolism and excretion (ADME) of the ALK inhibitor alectinib: results from an absolute bioavailability and mass balance study in healthy subjects.

Morcos PN, Yu L, Bogman K, Sato M, Katsuki H, Kawashima K, Moore DJ, Whayman M, Nieforth K, Heinig K, Guerini E, Muri D, Martin-Facklam M, Phipps A.

Xenobiotica. 2017 Mar;47(3):217-229. doi: 10.1080/00498254.2016.1179821. Epub 2016 May 16.


Identification of new oral dosing regimens for the neuraminidase inhibitor oseltamivir in patients with moderate and severe renal impairment.

Kamal MA, Brennan BJ, Subramoney V, Lien YT, Morcos PN, Frey N, Rayner CR.

Clin Pharmacol Drug Dev. 2015 Sep;4(5):326-36. doi: 10.1002/cpdd.203. Epub 2015 Jul 2.


Ritonavir-boosted danoprevir-based regimens in treatment-naive and prior null responders with HCV genotype 1 or 4 and compensated cirrhosis.

Gane EJ, Rouzier R, Hassanein T, Stedman CA, Mazur W, Kupcova V, Le Pogam S, Eng S, Voulgari A, Morcos PN, Brennan BJ, Scalori A, Thommes J.

Hepatol Int. 2016 May;10(3):478-87. doi: 10.1007/s12072-015-9699-9. Epub 2016 Feb 17.


Alectinib in Crizotinib-Refractory ALK-Rearranged Non-Small-Cell Lung Cancer: A Phase II Global Study.

Ou SH, Ahn JS, De Petris L, Govindan R, Yang JC, Hughes B, Lena H, Moro-Sibilot D, Bearz A, Ramirez SV, Mekhail T, Spira A, Bordogna W, Balas B, Morcos PN, Monnet A, Zeaiter A, Kim DW.

J Clin Oncol. 2016 Mar 1;34(7):661-8. doi: 10.1200/JCO.2015.63.9443. Epub 2015 Nov 23.


Challenges and Opportunities for Quantitative Clinical Pharmacology in Cancer Immunotherapy: Something Old, Something New, Something Borrowed, and Something Blue.

Stroh M, Carlile DJ, Li CC, Wagg J, Ribba B, Ramanujan S, Jin J, Xu J, Charoin JE, Xhu ZX, Morcos PN, Davis JD, Phipps A.

CPT Pharmacometrics Syst Pharmacol. 2015 Sep;4(9):495-7. doi: 10.1002/psp4.12014. Epub 2015 Sep 11.


Effect of a modified saquinavir/ritonavir dosing regimen with lower dose lead-in phase on QTc interval, pharmacokinetics, antiviral activity and safety in treatment-naïve HIV-1-infected patients.

Boffito M, Jackson A, Pozniak A, Giraudon M, Kulkarni R, Abelardo MC, Patel IH, Morcos PN.

Drugs R D. 2015 Mar;15(1):141-53. doi: 10.1007/s40268-015-0087-7.


Characterization of the transmembrane transport and absolute bioavailability of the HCV protease inhibitor danoprevir.

Brennan BJ, Poirier A, Moreira S, Morcos PN, Goelzer P, Portmann R, Asthappan J, Funk C, Smith PF.

Clin Pharmacokinet. 2015 May;54(5):537-49. doi: 10.1007/s40262-014-0222-6.


Pharmacokinetics and safety of oseltamivir in patients with end-stage renal disease treated with automated peritoneal dialysis.

Patel K, Rayner CR, Giraudon M, Kamal MA, Morcos PN, Robson R, Kirkpatrick CM.

Br J Clin Pharmacol. 2015 Apr;79(4):624-35. doi: 10.1111/bcp.12526.


Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study.

Gadgeel SM, Gandhi L, Riely GJ, Chiappori AA, West HL, Azada MC, Morcos PN, Lee RM, Garcia L, Yu L, Boisserie F, Di Laurenzio L, Golding S, Sato J, Yokoyama S, Tanaka T, Ou SH.

Lancet Oncol. 2014 Sep;15(10):1119-28. doi: 10.1016/S1470-2045(14)70362-6. Epub 2014 Aug 18.


Mericitabine and ritonavir-boosted danoprevir with or without ribavirin in treatment-naive HCV genotype 1 patients: INFORM-SVR study.

Gane EJ, Pockros PJ, Zeuzem S, Marcellin P, Shikhman A, Bernaards C, Zhou J, Yetzer ES, Ballester R, Dwyer C, Tong X, Nájera I, Bertasso A, Hammond J, Kindrick A, Morcos PN, Smith P, Stancic S, Shulman NS.

Liver Int. 2015 Jan;35(1):79-89. doi: 10.1111/liv.12588. Epub 2014 Jun 19.


Efficacy and safety of danoprevir-ritonavir plus peginterferon alfa-2a-ribavirin in hepatitis C virus genotype 1 prior null responders.

Gane EJ, Rouzier R, Wiercinska-Drapalo A, Larrey DG, Morcos PN, Brennan BJ, Le Pogam S, Nájera I, Petric R, Tran JQ, Kulkarni R, Zhang Y, Smith P, Yetzer ES, Shulman NS.

Antimicrob Agents Chemother. 2014;58(2):1136-45. doi: 10.1128/AAC.01515-13. Epub 2013 Dec 2.


Two-way interaction study between ritonavir boosted danoprevir, a potent HCV protease inhibitor, and ketoconazole in healthy subjects.

Morcos PN, Chang L, Navarro M, Chung D, Smith PF, Brennan BJ, Tran JQ.

Int J Clin Pharmacol Ther. 2014 Feb;52(2):103-11. doi: 10.5414/CP201922.


Effect of meal and antisecretory agents on the pharmacokinetics of danoprevir/ritonavir in healthy volunteers.

Morcos PN, Moreira SA, Navarro MT, Bech N, Quatkemeyer A, Smith PF, Brennan BJ.

J Pharm Pharmacol. 2014 Jan;66(1):23-31. doi: 10.1111/jphp.12151. Epub 2013 Oct 10.


Effect of ritonavir-boosted danoprevir, a potent hepatitis C virus protease inhibitor, on the pharmacokinetics of methadone in healthy subjects undergoing methadone maintenance therapy.

Moreira SA, Morcos PN, Navarro MT, Bech N, Smith PF, Brennan BJ.

Pharmacotherapy. 2014 Mar;34(3):220-6. doi: 10.1002/phar.1341. Epub 2013 Aug 14.


A randomised study of the effect of danoprevir/ritonavir or ritonavir on substrates of cytochrome P450 (CYP) 3A and 2C9 in chronic hepatitis C patients using a drug cocktail.

Morcos PN, Chang L, Kulkarni R, Giraudon M, Shulman N, Brennan BJ, Smith PF, Tran JQ.

Eur J Clin Pharmacol. 2013 Nov;69(11):1939-49. doi: 10.1007/s00228-013-1556-y. Epub 2013 Jul 20.


Influence of chronic hepatitis C infection on cytochrome P450 3A4 activity using midazolam as an in vivo probe substrate.

Morcos PN, Moreira SA, Brennan BJ, Blotner S, Shulman NS, Smith PF.

Eur J Clin Pharmacol. 2013 Oct;69(10):1777-84. doi: 10.1007/s00228-013-1525-5. Epub 2013 Jun 14.


Pharmacokinetics of a three-way drug interaction between danoprevir, ritonavir and the organic anion transporting polypeptide (OATP) inhibitor ciclosporin.

Brennan BJ, Moreira SA, Morcos PN, Navarro MT, Asthappan J, Goelzer P, Weigl P, Smith PF.

Clin Pharmacokinet. 2013 Sep;52(9):805-13. doi: 10.1007/s40262-013-0077-2.


Pharmacokinetics and pharmacodynamics of single subcutaneous doses of tocilizumab administered with or without rHuPH20.

Morcos PN, Zhang X, McIntyre C, Bittner B, Rowell L, Hussain Z.

Int J Clin Pharmacol Ther. 2013 Jul;51(7):537-48. doi: 10.5414/CP201847.


Clinical pharmacology of tocilizumab for the treatment of systemic juvenile idiopathic arthritis.

Zhang X, Morcos PN, Saito T, Terao K.

Expert Rev Clin Pharmacol. 2013 Mar;6(2):123-37. doi: 10.1586/ecp.13.1. Review.


Safety, tolerability, and pharmacokinetics of intravenous oseltamivir: single- and multiple-dose phase I studies with healthy volunteers.

Brennan BJ, Davies B, Cirrincione-Dall G, Morcos PN, Beryozkina A, Chappey C, Aceves Baldó P, Lennon-Chrimes S, Rayner CR.

Antimicrob Agents Chemother. 2012 Sep;56(9):4729-37. doi: 10.1128/AAC.00200-12. Epub 2012 Jun 25.


Pharmacokinetic/Pharmacodynamic predictors of clinical potency for hepatitis C virus nonnucleoside polymerase and protease inhibitors.

Reddy MB, Morcos PN, Le Pogam S, Ou Y, Frank K, Lave T, Smith P.

Antimicrob Agents Chemother. 2012 Jun;56(6):3144-56. doi: 10.1128/AAC.06283-11. Epub 2012 Apr 2.


The pharmacokinetics of peginterferon alfa-2a and ribavirin in African American, Hispanic and Caucasian patients with chronic hepatitis C.

Brennan BJ, Morcos PN, Wang K, Blotner SD, Morrison R, Hagedorn CH, Marbury TC, Sulkowski M, Grippo JF.

Aliment Pharmacol Ther. 2012 May;35(10):1209-20. doi: 10.1111/j.1365-2036.2012.05079.x. Epub 2012 Apr 3.


Physiological modeling and assessments of regional drug bioavailability of danoprevir to determine whether a controlled release formulation is feasible.

Reddy MB, Connor A, Brennan BJ, Morcos PN, Zhou A, McLawhon P, Fretland A, Evans P, Smith P, Tran JQ.

Biopharm Drug Dispos. 2011 Jul;32(5):261-75. doi: 10.1002/bdd.756. Epub 2011 Jun 9.


Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial.

Gane EJ, Roberts SK, Stedman CA, Angus PW, Ritchie B, Elston R, Ipe D, Morcos PN, Baher L, Najera I, Chu T, Lopatin U, Berrey MM, Bradford W, Laughlin M, Shulman NS, Smith PF.

Lancet. 2010 Oct 30;376(9751):1467-75. doi: 10.1016/S0140-6736(10)61384-0. Epub 2010 Oct 14.


Effect of saquinavir/ritonavir (1000/100 mg bid) on the pharmacokinetics of methadone in opiate-dependent HIV-negative patients on stable methadone maintenance therapy.

Jamois C, Smith P, Morrison R, Riek M, Patel A, Schmitt C, Morcos PN, Zhang X.

Addict Biol. 2009 Jul;14(3):321-7. doi: 10.1111/j.1369-1600.2009.00158.x.


A grapefruit a day for patients infected with hepatitis C?

Morcos PN, Brennan B, Smith PF.

Hepatology. 2008 Jun;47(6):2141-2; author reply 2142-3. doi: 10.1002/hep.22308. No abstract available.


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