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Items: 1 to 50 of 80

1.

Dose-escalation trial of the ALK, MET & ROS1 inhibitor, crizotinib, in patients with advanced cancer.

Clark JW, Camidge DR, Kwak EL, Maki RG, Shapiro GI, Chen I, Tan W, Randolph S, Christensen JG, Ozeck M, Tang Y, Wilner KD, Salgia R.

Future Oncol. 2019 Nov 28. doi: 10.2217/fon-2019-0653. [Epub ahead of print]

PMID:
31778074
2.

Systematic review and network meta-analysis of first-line therapy for advanced EGFR-positive non-small-cell lung cancer.

Franek J, Cappelleri JC, Larkin-Kaiser KA, Wilner KD, Sandin R.

Future Oncol. 2019 Aug;15(24):2857-2871. doi: 10.2217/fon-2019-0270. Epub 2019 Jul 12.

PMID:
31298572
3.

Clinical implications of an analysis of pharmacokinetics of crizotinib coadministered with dexamethasone in patients with non-small cell lung cancer.

Lin S, Nickens DJ, Patel M, Wilner KD, Tan W.

Cancer Chemother Pharmacol. 2019 Jul;84(1):203-211. doi: 10.1007/s00280-019-03861-y. Epub 2019 May 24.

PMID:
31127319
4.

Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001.

Shaw AT, Riely GJ, Bang YJ, Kim DW, Camidge DR, Solomon BJ, Varella-Garcia M, Iafrate AJ, Shapiro GI, Usari T, Wang SC, Wilner KD, Clark JW, Ou SI.

Ann Oncol. 2019 Jul 1;30(7):1121-1126. doi: 10.1093/annonc/mdz131.

5.

Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC.

Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD.

J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.

PMID:
30822515
6.

Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer.

Wilner KD, Usari T, Polli A, Kim EE.

Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.

PMID:
30652510
7.

Correlation of extent of ALK FISH positivity and crizotinib efficacy in three prospective studies of ALK-positive patients with non-small-cell lung cancer.

Soria JC, Ho SN, Varella-Garcia M, Iafrate AJ, Solomon BJ, Shaw AT, Blackhall F, Mok TS, Wu YL, Pestova K, Wilner KD, Polli A, Paolini J, Lanzalone S, Green S, Camidge DR.

Ann Oncol. 2018 Sep 1;29(9):1964-1971. doi: 10.1093/annonc/mdy242.

PMID:
30010763
8.

Results of PROFILE 1029, a Phase III Comparison of First-Line Crizotinib versus Chemotherapy in East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer.

Wu YL, Lu S, Lu Y, Zhou J, Shi YK, Sriuranpong V, Ho JCM, Ong CK, Tsai CM, Chung CH, Wilner KD, Tang Y, Masters ET, Selaru P, Mok TS.

J Thorac Oncol. 2018 Oct;13(10):1539-1548. doi: 10.1016/j.jtho.2018.06.012. Epub 2018 Aug 14.

9.

Final Overall Survival Analysis From a Study Comparing First-Line Crizotinib Versus Chemotherapy in ALK-Mutation-Positive Non-Small-Cell Lung Cancer.

Solomon BJ, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Tang Y, Wilner KD, Blackhall F, Mok TS.

J Clin Oncol. 2018 Aug 1;36(22):2251-2258. doi: 10.1200/JCO.2017.77.4794. Epub 2018 May 16.

PMID:
29768118
10.

Phase II Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced Non-Small-Cell Lung Cancer.

Wu YL, Yang JC, Kim DW, Lu S, Zhou J, Seto T, Yang JJ, Yamamoto N, Ahn MJ, Takahashi T, Yamanaka T, Kemner A, Roychowdhury D, Paolini J, Usari T, Wilner KD, Goto K.

J Clin Oncol. 2018 May 10;36(14):1405-1411. doi: 10.1200/JCO.2017.75.5587. Epub 2018 Mar 29.

PMID:
29596029
11.

Palbociclib has no clinically relevant effect on the QTc interval in patients with advanced breast cancer.

Durairaj C, Ruiz-Garcia A, Gauthier ER, Huang X, Lu DR, Hoffman JT, Finn RS, Joy AA, Ettl J, Rugo HS, Zheng J, Wilner KD, Wang DD.

Anticancer Drugs. 2018 Mar;29(3):271-280. doi: 10.1097/CAD.0000000000000589.

12.

Final results of the large-scale multinational trial PROFILE 1005: efficacy and safety of crizotinib in previously treated patients with advanced/metastatic ALK-positive non-small-cell lung cancer.

Blackhall F, Ross Camidge D, Shaw AT, Soria JC, Solomon BJ, Mok T, Hirsh V, Jänne PA, Shi Y, Yang PC, Pas T, Hida T, Carpeño JC, Lanzalone S, Polli A, Iyer S, Reisman A, Wilner KD, Kim DW.

ESMO Open. 2017 Aug 17;2(3):e000219. doi: 10.1136/esmoopen-2017-000219. eCollection 2017.

13.

Crizotinib versus Chemotherapy in Asian Patients with ALK-Positive Advanced Non-small Cell Lung Cancer.

Nishio M, Kim DW, Wu YL, Nakagawa K, Solomon BJ, Shaw AT, Hashigaki S, Ohki E, Usari T, Paolini J, Polli A, Wilner KD, Mok T.

Cancer Res Treat. 2018 Jul;50(3):691-700. doi: 10.4143/crt.2017.280. Epub 2017 Jul 6.

14.

Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials.

Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS.

Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.

PMID:
28373069
15.

Clinical Implications of the Pharmacokinetics of Crizotinib in Populations of Patients with Non-Small Cell Lung Cancer.

Wang E, Nickens DJ, Bello A, Khosravan R, Amantea M, Wilner KD, Parivar K, Tan W.

Clin Cancer Res. 2016 Dec 1;22(23):5722-5728. Epub 2016 Jun 8.

16.

Intracranial Efficacy of Crizotinib Versus Chemotherapy in Patients With Advanced ALK-Positive Non-Small-Cell Lung Cancer: Results From PROFILE 1014.

Solomon BJ, Cappuzzo F, Felip E, Blackhall FH, Costa DB, Kim DW, Nakagawa K, Wu YL, Mekhail T, Paolini J, Tursi J, Usari T, Wilner KD, Selaru P, Mok TS.

J Clin Oncol. 2016 Aug 20;34(24):2858-65. doi: 10.1200/JCO.2015.63.5888. Epub 2016 Mar 28.

PMID:
27022118
17.

Sufficiency of Single-Arm Studies to Support Registration of Targeted Agents in Molecularly Selected Patients with Cancer: Lessons from the Clinical Development of Crizotinib.

Selaru P, Tang Y, Huang B, Polli A, Wilner KD, Donnelly E, Cohen DP.

Clin Transl Sci. 2016 Apr;9(2):63-73. doi: 10.1111/cts.12388. Epub 2016 Mar 1. Review. No abstract available.

18.

Factors associated with sinus bradycardia during crizotinib treatment: a retrospective analysis of two large-scale multinational trials (PROFILE 1005 and 1007).

Ou SH, Tang Y, Polli A, Wilner KD, Schnell P.

Cancer Med. 2016 Apr;5(4):617-22. doi: 10.1002/cam4.622. Epub 2016 Jan 28.

19.

Complex renal cysts associated with crizotinib treatment.

Schnell P, Bartlett CH, Solomon BJ, Tassell V, Shaw AT, de Pas T, Lee SH, Lee GK, Tanaka K, Tan W, Tang Y, Wilner KD, Safferman A, Han JY.

Cancer Med. 2015 Jun;4(6):887-96. doi: 10.1002/cam4.437. Epub 2015 Mar 10.

20.

Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases.

Costa DB, Shaw AT, Ou SH, Solomon BJ, Riely GJ, Ahn MJ, Zhou C, Shreeve SM, Selaru P, Polli A, Schnell P, Wilner KD, Wiltshire R, Camidge DR, Crinò L.

J Clin Oncol. 2015 Jun 10;33(17):1881-8. doi: 10.1200/JCO.2014.59.0539. Epub 2015 Jan 26.

21.

First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

Solomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J, Blackhall F; PROFILE 1014 Investigators.

N Engl J Med. 2014 Dec 4;371(23):2167-77. doi: 10.1056/NEJMoa1408440. Erratum in: N Engl J Med. 2015 Oct 15;373(16):1582.

22.

Patient-reported outcomes and quality of life in PROFILE 1007: a randomized trial of crizotinib compared with chemotherapy in previously treated patients with ALK-positive advanced non-small-cell lung cancer.

Blackhall F, Kim DW, Besse B, Nokihara H, Han JY, Wilner KD, Reisman A, Iyer S, Hirsh V, Shaw AT.

J Thorac Oncol. 2014 Nov;9(11):1625-33. doi: 10.1097/JTO.0000000000000318. Erratum in: J Thorac Oncol. 2015 Nov;10(11):1657.

23.

Crizotinib in ROS1-rearranged non-small-cell lung cancer.

Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ.

N Engl J Med. 2014 Nov 20;371(21):1963-71. doi: 10.1056/NEJMoa1406766. Epub 2014 Sep 27.

24.

Current status of targeted therapy for anaplastic lymphoma kinase-rearranged non-small cell lung cancer.

Solomon B, Wilner KD, Shaw AT.

Clin Pharmacol Ther. 2014 Jan;95(1):15-23. doi: 10.1038/clpt.2013.200. Epub 2013 Oct 3. Review.

PMID:
24091716
25.

Acquired resistance to crizotinib from a mutation in CD74-ROS1.

Awad MM, Katayama R, McTigue M, Liu W, Deng YL, Brooun A, Friboulet L, Huang D, Falk MD, Timofeevski S, Wilner KD, Lockerman EL, Khan TM, Mahmood S, Gainor JF, Digumarthy SR, Stone JR, Mino-Kenudson M, Christensen JG, Iafrate AJ, Engelman JA, Shaw AT.

N Engl J Med. 2013 Jun 20;368(25):2395-401. doi: 10.1056/NEJMoa1215530. Epub 2013 Jun 1.

26.

Crizotinib versus chemotherapy in advanced ALK-positive lung cancer.

Shaw AT, Kim DW, Nakagawa K, Seto T, Crinó L, Ahn MJ, De Pas T, Besse B, Solomon BJ, Blackhall F, Wu YL, Thomas M, O'Byrne KJ, Moro-Sibilot D, Camidge DR, Mok T, Hirsh V, Riely GJ, Iyer S, Tassell V, Polli A, Wilner KD, Jänne PA.

N Engl J Med. 2013 Jun 20;368(25):2385-94. doi: 10.1056/NEJMoa1214886. Epub 2013 Jun 1. Erratum in: N Engl J Med. 2015 Oct 15;373(16):1582.

27.

Selective CDK4/6 inhibition with tumor responses by PD0332991 in patients with mantle cell lymphoma.

Leonard JP, LaCasce AS, Smith MR, Noy A, Chirieac LR, Rodig SJ, Yu JQ, Vallabhajosula S, Schoder H, English P, Neuberg DS, Martin P, Millenson MM, Ely SA, Courtney R, Shaik N, Wilner KD, Randolph S, Van den Abbeele AD, Chen-Kiang SY, Yap JT, Shapiro GI.

Blood. 2012 May 17;119(20):4597-607. doi: 10.1182/blood-2011-10-388298. Epub 2012 Mar 1.

PMID:
22383795
28.

ROS1 rearrangements define a unique molecular class of lung cancers.

Bergethon K, Shaw AT, Ou SH, Katayama R, Lovly CM, McDonald NT, Massion PP, Siwak-Tapp C, Gonzalez A, Fang R, Mark EJ, Batten JM, Chen H, Wilner KD, Kwak EL, Clark JW, Carbone DP, Ji H, Engelman JA, Mino-Kenudson M, Pao W, Iafrate AJ.

J Clin Oncol. 2012 Mar 10;30(8):863-70. doi: 10.1200/JCO.2011.35.6345. Epub 2012 Jan 3.

29.

Rapid radiographic and clinical improvement after treatment of a MET-amplified recurrent glioblastoma with a mesenchymal-epithelial transition inhibitor.

Chi AS, Batchelor TT, Kwak EL, Clark JW, Wang DL, Wilner KD, Louis DN, Iafrate AJ.

J Clin Oncol. 2012 Jan 20;30(3):e30-3. doi: 10.1200/JCO.2011.38.4586. Epub 2011 Dec 12. No abstract available.

PMID:
22162573
30.

Phase I, dose-escalation trial of the oral cyclin-dependent kinase 4/6 inhibitor PD 0332991, administered using a 21-day schedule in patients with advanced cancer.

Flaherty KT, Lorusso PM, Demichele A, Abramson VG, Courtney R, Randolph SS, Shaik MN, Wilner KD, O'Dwyer PJ, Schwartz GK.

Clin Cancer Res. 2012 Jan 15;18(2):568-76. doi: 10.1158/1078-0432.CCR-11-0509. Epub 2011 Nov 16.

31.

MET amplification identifies a small and aggressive subgroup of esophagogastric adenocarcinoma with evidence of responsiveness to crizotinib.

Lennerz JK, Kwak EL, Ackerman A, Michael M, Fox SB, Bergethon K, Lauwers GY, Christensen JG, Wilner KD, Haber DA, Salgia R, Bang YJ, Clark JW, Solomon BJ, Iafrate AJ.

J Clin Oncol. 2011 Dec 20;29(36):4803-10. doi: 10.1200/JCO.2011.35.4928. Epub 2011 Oct 31.

32.

Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis.

Shaw AT, Yeap BY, Solomon BJ, Riely GJ, Gainor J, Engelman JA, Shapiro GI, Costa DB, Ou SH, Butaney M, Salgia R, Maki RG, Varella-Garcia M, Doebele RC, Bang YJ, Kulig K, Selaru P, Tang Y, Wilner KD, Kwak EL, Clark JW, Iafrate AJ, Camidge DR.

Lancet Oncol. 2011 Oct;12(11):1004-12. doi: 10.1016/S1470-2045(11)70232-7. Epub 2011 Sep 18.

33.

Activity of crizotinib (PF02341066), a dual mesenchymal-epithelial transition (MET) and anaplastic lymphoma kinase (ALK) inhibitor, in a non-small cell lung cancer patient with de novo MET amplification.

Ou SH, Kwak EL, Siwak-Tapp C, Dy J, Bergethon K, Clark JW, Camidge DR, Solomon BJ, Maki RG, Bang YJ, Kim DW, Christensen J, Tan W, Wilner KD, Salgia R, Iafrate AJ.

J Thorac Oncol. 2011 May;6(5):942-6. doi: 10.1097/JTO.0b013e31821528d3.

34.

Phase I study of PD 0332991, a cyclin-dependent kinase inhibitor, administered in 3-week cycles (Schedule 2/1).

Schwartz GK, LoRusso PM, Dickson MA, Randolph SS, Shaik MN, Wilner KD, Courtney R, O'Dwyer PJ.

Br J Cancer. 2011 Jun 7;104(12):1862-8. doi: 10.1038/bjc.2011.177. Epub 2011 May 24.

35.

CSF concentration of the anaplastic lymphoma kinase inhibitor crizotinib.

Costa DB, Kobayashi S, Pandya SS, Yeo WL, Shen Z, Tan W, Wilner KD.

J Clin Oncol. 2011 May 20;29(15):e443-5. doi: 10.1200/JCO.2010.34.1313. Epub 2011 Mar 21. No abstract available.

PMID:
21422405
36.

Rapid and dramatic radiographic and clinical response to an ALK inhibitor (crizotinib, PF02341066) in an ALK translocation-positive patient with non-small cell lung cancer.

Ou SH, Bazhenova L, Camidge DR, Solomon BJ, Herman J, Kain T, Bang YJ, Kwak EL, Shaw AT, Salgia R, Maki RG, Clark JW, Wilner KD, Iafrate AJ.

J Thorac Oncol. 2010 Dec;5(12):2044-6. doi: 10.1097/JTO.0b013e318200f9ff. No abstract available.

37.

Prediction of oral pharmacokinetics of cMet kinase inhibitors in humans: physiologically based pharmacokinetic model versus traditional one-compartment model.

Yamazaki S, Skaptason J, Romero D, Vekich S, Jones HM, Tan W, Wilner KD, Koudriakova T.

Drug Metab Dispos. 2011 Mar;39(3):383-93. doi: 10.1124/dmd.110.035857. Epub 2010 Nov 23.

PMID:
21098644
38.

Crizotinib in ALK-rearranged inflammatory myofibroblastic tumor.

Butrynski JE, D'Adamo DR, Hornick JL, Dal Cin P, Antonescu CR, Jhanwar SC, Ladanyi M, Capelletti M, Rodig SJ, Ramaiya N, Kwak EL, Clark JW, Wilner KD, Christensen JG, Jänne PA, Maki RG, Demetri GD, Shapiro GI.

N Engl J Med. 2010 Oct 28;363(18):1727-33. doi: 10.1056/NEJMoa1007056.

39.

A phase II study of PD-0325901, an oral MEK inhibitor, in previously treated patients with advanced non-small cell lung cancer.

Haura EB, Ricart AD, Larson TG, Stella PJ, Bazhenova L, Miller VA, Cohen RB, Eisenberg PD, Selaru P, Wilner KD, Gadgeel SM.

Clin Cancer Res. 2010 Apr 15;16(8):2450-7. doi: 10.1158/1078-0432.CCR-09-1920. Epub 2010 Mar 23.

40.

Phase I pharmacokinetic and pharmacodynamic study of the oral MAPK/ERK kinase inhibitor PD-0325901 in patients with advanced cancers.

LoRusso PM, Krishnamurthi SS, Rinehart JJ, Nabell LM, Malburg L, Chapman PB, DePrimo SE, Bentivegna S, Wilner KD, Tan W, Ricart AD.

Clin Cancer Res. 2010 Mar 15;16(6):1924-37. doi: 10.1158/1078-0432.CCR-09-1883. Epub 2010 Mar 9.

41.

Pharmacokinetics/genotype associations for major cytochrome P450 enzymes in native and first- and third-generation Japanese populations: comparison with Korean, Chinese, and Caucasian populations.

Myrand SP, Sekiguchi K, Man MZ, Lin X, Tzeng RY, Teng CH, Hee B, Garrett M, Kikkawa H, Lin CY, Eddy SM, Dostalik J, Mount J, Azuma J, Fujio Y, Jang IJ, Shin SG, Bleavins MR, Williams JA, Paulauskis JD, Wilner KD.

Clin Pharmacol Ther. 2008 Sep;84(3):347-61. doi: 10.1038/sj.clpt.6100482. Epub 2008 Mar 19.

PMID:
18231117
42.

Pharmacokinetics, safety, and tolerability of intramuscular ziprasidone in healthy volunteers.

Miceli JJ, Wilner KD, Swan SK, Tensfeldt TG.

J Clin Pharmacol. 2005 Jun;45(6):620-30.

PMID:
15901743
43.

Celecoxib does not affect the antiplatelet activity of aspirin in healthy volunteers.

Wilner KD, Rushing M, Walden C, Adler R, Eskra J, Noveck R, Vargas R.

J Clin Pharmacol. 2002 Sep;42(9):1027-30.

PMID:
12211219
44.

The anxiolytic effect of the novel antipsychotic ziprasidone compared with diazepam in subjects anxious before dental surgery.

Wilner KD, Anziano RJ, Johnson AC, Miceli JJ, Fricke JR, Titus CK.

J Clin Psychopharmacol. 2002 Apr;22(2):206-10.

PMID:
11910268
45.

The effects of ziprasidone on steady-state lithium levels and renal clearance of lithium.

Apseloff G, Mullet D, Wilner KD, Anziano RJ, Tensfeldt TG, Pelletier SM, Gerber N.

Br J Clin Pharmacol. 2000;49 Suppl 1:61S-64S.

46.

The pharmacokinetics of ziprasidone in healthy volunteers treated with cimetidine or antacid.

Wilner KD, Hansen RA, Folger CJ, Geoffroy P.

Br J Clin Pharmacol. 2000;49 Suppl 1:57S-60S.

47.

Ziprasidone and the activity of cytochrome P450 2D6 in healthy extensive metabolizers.

Wilner KD, Demattos SB, Anziano RJ, Apseloff G, Gerber N.

Br J Clin Pharmacol. 2000;49 Suppl 1:43S-47S.

48.

The pharmacokinetics of ziprasidone in subjects with normal and impaired renal function.

Aweeka F, Jayesekara D, Horton M, Swan S, Lambrecht L, Wilner KD, Sherwood J, Anziano RJ, Smolarek TA, Turncliff RZ.

Br J Clin Pharmacol. 2000;49 Suppl 1:27S-33S.

49.

The pharmacokinetics of ziprasidone in subjects with normal and impaired hepatic function.

Everson G, Lasseter KC, Anderson KE, Bauer LA, Carithens RL Jr, Wilner KD, Johnson A, Anziano RJ, Smolarek TA, Turncliff RZ.

Br J Clin Pharmacol. 2000;49 Suppl 1:21S-26S.

50.

Single- and multiple-dose pharmacokinetics of ziprasidone in healthy young and elderly volunteers.

Wilner KD, Tensfeldt TG, Baris B, Smolarek TA, Turncliff RZ, Colburn WA, Hansen RA.

Br J Clin Pharmacol. 2000;49 Suppl 1:15S-20S.

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