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Items: 1 to 50 of 179

1.

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.

2.

Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.

Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O'Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ.

Value Health. 2018 Jun;21(6):742-747. doi: 10.1016/j.jval.2017.09.009. Epub 2017 Nov 7.

3.

Residual Symptoms After Treatment for Depression in Patients With Coronary Heart Disease.

Carney RM, Freedland KE, Steinmeyer BC, Rubin EH, Rich MW.

Psychosom Med. 2018 May;80(4):385-392. doi: 10.1097/PSY.0000000000000570.

PMID:
29521883
4.

Development of MK-8353, an orally administered ERK1/2 inhibitor, in patients with advanced solid tumors.

Moschos SJ, Sullivan RJ, Hwu WJ, Ramanathan RK, Adjei AA, Fong PC, Shapira-Frommer R, Tawbi HA, Rubino J, Rush TS 3rd, Zhang D, Miselis NR, Samatar AA, Chun P, Rubin EH, Schiller J, Long BJ, Dayananth P, Carr D, Kirschmeier P, Bishop WR, Deng Y, Cooper A, Shipps GW, Moreno BH, Robert L, Ribas A, Flaherty KT.

JCI Insight. 2018 Feb 22;3(4). pii: 92352. doi: 10.1172/jci.insight.92352. [Epub ahead of print]

5.

Report on the Third FDA-AACR Oncology Dose-Finding Workshop.

Emens LA, Bruno R, Rubin EH, Jaffee EM, McKee AE.

Cancer Immunol Res. 2017 Dec;5(12):1058-1061. doi: 10.1158/2326-6066.CIR-17-0590.

PMID:
29196440
6.

A 2-in-1 adaptive phase 2/3 design for expedited oncology drug development.

Chen C, Anderson K, Mehrotra DV, Rubin EH, Tse A.

Contemp Clin Trials. 2018 Jan;64:238-242. doi: 10.1016/j.cct.2017.09.006. Epub 2017 Sep 28.

PMID:
28966137
7.

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
8.

Immuno-oncology Clinical Trial Design: Limitations, Challenges, and Opportunities.

Baik CS, Rubin EH, Forde PM, Mehnert JM, Collyar D, Butler MO, Dixon EL, Chow LQM.

Clin Cancer Res. 2017 Sep 1;23(17):4992-5002. doi: 10.1158/1078-0432.CCR-16-3066.

9.

From Famine to Feast: Developing Early-Phase Combination Immunotherapy Trials Wisely.

Day D, Monjazeb AM, Sharon E, Ivy SP, Rubin EH, Rosner GL, Butler MO.

Clin Cancer Res. 2017 Sep 1;23(17):4980-4991. doi: 10.1158/1078-0432.CCR-16-3064.

10.

Strategies to Maximize Patient Participation in Clinical Trials.

Rubin EH, Scroggins MJ, Goldberg KB, Beaver JA.

Am Soc Clin Oncol Educ Book. 2017;37:216-221. doi: 10.14694/EDBK_179803.

11.

How many tumor indications should be initially screened in development of next generation immunotherapies?

Chen C, Deng Q, He L, Mehrotra DV, Rubin EH, Beckman RA.

Contemp Clin Trials. 2017 Aug;59:113-117. doi: 10.1016/j.cct.2017.03.012. Epub 2017 Mar 21.

PMID:
28341249
12.

Clinical predictors of depression treatment outcomes in patients with coronary heart disease.

Carney RM, Freedland KE, Steinmeyer BC, Rubin EH, Rich MW.

J Psychosom Res. 2016 Sep;88:36-41. doi: 10.1016/j.jpsychores.2016.07.011. Epub 2016 Jul 19.

13.

The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer.

Papadimitrakopoulou V, Lee JJ, Wistuba II, Tsao AS, Fossella FV, Kalhor N, Gupta S, Byers LA, Izzo JG, Gettinger SN, Goldberg SB, Tang X, Miller VA, Skoulidis F, Gibbons DL, Shen L, Wei C, Diao L, Peng SA, Wang J, Tam AL, Coombes KR, Koo JS, Mauro DJ, Rubin EH, Heymach JV, Hong WK, Herbst RS.

J Clin Oncol. 2016 Oct 20;34(30):3638-3647. doi: 10.1200/JCO.2015.66.0084.

14.

Collaborative care for depression symptoms in an outpatient cardiology setting: A randomized clinical trial.

Carney RM, Freedland KE, Steinmeyer BC, Rubin EH, Ewald G.

Int J Cardiol. 2016 Sep 15;219:164-71. doi: 10.1016/j.ijcard.2016.06.045. Epub 2016 Jun 14.

15.

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.

16.

Nighttime heart rate predicts response to depression treatment in patients with coronary heart disease.

Carney RM, Freedland KE, Steinmeyer BC, Rubin EH, Stein PK, Rich MW.

J Affect Disord. 2016 Aug;200:165-71. doi: 10.1016/j.jad.2016.04.051. Epub 2016 Apr 25.

17.

Baseline blood levels of omega-3 and depression remission: a secondary analysis of data from a placebo-controlled trial of omega-3 supplements.

Carney RM, Steinmeyer BC, Freedland KE, Rubin EH, Rich MW, Harris WS.

J Clin Psychiatry. 2016 Feb;77(2):e138-43. doi: 10.4088/JCP.14m09660.

18.

Advancing Clinical Trials to Streamline Drug Development.

Bates SE, Berry DA, Balasubramaniam S, Bailey S, LoRusso PM, Rubin EH.

Clin Cancer Res. 2015 Oct 15;21(20):4527-35. doi: 10.1158/1078-0432.CCR-15-0039.

19.

Cardiac Risk Markers and Response to Depression Treatment in Patients With Coronary Heart Disease.

Carney RM, Freedland KE, Steinmeyer B, Rubin EH, Mann DL, Rich MW.

Psychosom Med. 2016 Jan;78(1):49-59. doi: 10.1097/PSY.0000000000000245.

20.

Cognitive Behavior Therapy for Depression and Self-Care in Heart Failure Patients: A Randomized Clinical Trial.

Freedland KE, Carney RM, Rich MW, Steinmeyer BC, Rubin EH.

JAMA Intern Med. 2015 Nov;175(11):1773-82. doi: 10.1001/jamainternmed.2015.5220.

21.

Antitumor activity in RAS-driven tumors by blocking AKT and MEK.

Tolcher AW, Khan K, Ong M, Banerji U, Papadimitrakopoulou V, Gandara DR, Patnaik A, Baird RD, Olmos D, Garrett CR, Skolnik JM, Rubin EH, Smith PD, Huang P, Learoyd M, Shannon KA, Morosky A, Tetteh E, Jou YM, Papadopoulos KP, Moreno V, Kaiser B, Yap TA, Yan L, de Bono JS.

Clin Cancer Res. 2015 Feb 15;21(4):739-48. doi: 10.1158/1078-0432.CCR-14-1901. Epub 2014 Dec 16.

22.

AACR Cancer Progress Report 2014.

Arteaga CL, Adamson PC, Engelman JA, Foti M, Gaynor RB, Hilsenbeck SG, Limburg PJ, Lowe SW, Mardis ER, Ramsey S, Rebbeck TR, Richardson AL, Rubin EH, Weiner GJ.

Clin Cancer Res. 2014 Oct 1;20(19 Suppl):S1-S112. doi: 10.1158/1078-0432.CCR-14-2123. Epub 2014 Sep 16. No abstract available.

23.

Developing precision medicine in a global world.

Rubin EH, Allen JD, Nowak JA, Bates SE.

Clin Cancer Res. 2014 Mar 15;20(6):1419-27. doi: 10.1158/1078-0432.CCR-14-0091. Review.

24.

E5501: phase II study of topotecan sequenced with etoposide/cisplatin, and irinotecan/cisplatin sequenced with etoposide for extensive-stage small-cell lung cancer.

Owonikoko TK, Aisner J, Wang XV, Dahlberg SE, Rubin EH, Ramalingam SS, Gounder M, Rausch PG, Axelrod RS, Schiller JH.

Cancer Chemother Pharmacol. 2014 Jan;73(1):171-80. doi: 10.1007/s00280-013-2338-z. Epub 2013 Nov 28.

25.

Clinical pharmacology profile of vorinostat, a histone deacetylase inhibitor.

Iwamoto M, Friedman EJ, Sandhu P, Agrawal NG, Rubin EH, Wagner JA.

Cancer Chemother Pharmacol. 2013 Sep;72(3):493-508. doi: 10.1007/s00280-013-2220-z. Epub 2013 Jul 3. Review.

PMID:
23820962
26.

Phase I/IIa trial of the mammalian target of rapamycin inhibitor ridaforolimus (AP23573; MK-8669) administered orally in patients with refractory or advanced malignancies and sarcoma.

Mita MM, Poplin E, Britten CD, Tap WD, Rubin EH, Scott BB, Berk L, Rivera VM, Loewy JW, Dodion P, Haluska F, Sarantopoulos J, Mita A, Tolcher A.

Ann Oncol. 2013 Apr;24(4):1104-11. doi: 10.1093/annonc/mds602. Epub 2012 Dec 4.

PMID:
23211938
27.

The BATTLE trial: a bold step toward improving the efficiency of biomarker-based drug development.

Rubin EH, Anderson KM, Gause CK.

Cancer Discov. 2011 Jun;1(1):17-20. doi: 10.1158/2159-8274.CD-11-0036. Epub 2011 Jun 1.

28.

Perspective: Upcoming paradigm shifts for psychiatry in clinical care, research, and education.

Rubin EH, Zorumski CF.

Acad Med. 2012 Mar;87(3):261-5. doi: 10.1097/ACM.0b013e3182441697.

PMID:
22373615
29.

Drug development and clinical trials--the path to an approved cancer drug.

Rubin EH, Gilliland DG.

Nat Rev Clin Oncol. 2012 Feb 28;9(4):215-22. doi: 10.1038/nrclinonc.2012.22. Review.

PMID:
22371130
30.

Reports from the 2010 Clinical and Translational Cancer Research Think Tank meeting: design strategies for personalized therapy trials.

Berry DA, Herbst RS, Rubin EH.

Clin Cancer Res. 2012 Feb 1;18(3):638-44. doi: 10.1158/1078-0432.CCR-11-2018.

31.

A phase 1 trial of E7974 administered on day 1 of a 21-day cycle in patients with advanced solid tumors.

Rocha-Lima CM, Bayraktar S, Macintyre J, Raez L, Flores AM, Ferrell A, Rubin EH, Poplin EA, Tan AR, Lucarelli A, Zojwalla N.

Cancer. 2012 Sep 1;118(17):4262-70. doi: 10.1002/cncr.27428. Epub 2012 Jan 31.

32.

Adaptive clinical trial designs for simultaneous testing of matched diagnostics and therapeutics.

Scher HI, Nasso SF, Rubin EH, Simon R.

Clin Cancer Res. 2011 Nov 1;17(21):6634-40. doi: 10.1158/1078-0432.CCR-11-1105.

33.

Obstructive sleep apnea/hypopnea syndrome and poor response to sertraline in patients with coronary heart disease.

Roest AM, Carney RM, Stein PK, Freedland KE, Meyer H, Steinmeyer BC, de Jonge P, Rubin EH.

J Clin Psychiatry. 2012 Jan;73(1):31-6. doi: 10.4088/JCP.10m06455. Epub 2011 Aug 9.

34.

Rationally designed treatment for solid tumors with MAPK pathway activation: a phase I study of paclitaxel and bortezomib using an adaptive dose-finding approach.

Mehnert JM, Tan AR, Moss R, Poplin E, Stein MN, Sovak M, Levinson K, Lin H, Kane M, Gounder M, Lin Y, Shih WJ, White E, Rubin EH, Karantza V.

Mol Cancer Ther. 2011 Aug;10(8):1509-19. doi: 10.1158/1535-7163.MCT-10-0944. Epub 2011 Jun 16.

35.

Inflammation and treatment response to sertraline in patients with coronary heart disease and comorbid major depression.

Bot M, Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Mann DL.

J Psychosom Res. 2011 Jul;71(1):13-7. doi: 10.1016/j.jpsychores.2010.11.006. Epub 2011 Jan 15.

36.

Effect of omega-3 fatty acids on heart rate variability in depressed patients with coronary heart disease.

Carney RM, Freedland KE, Stein PK, Steinmeyer BC, Harris WS, Rubin EH, Krone RJ, Rich MW.

Psychosom Med. 2010 Oct;72(8):748-54. doi: 10.1097/PSY.0b013e3181eff148. Epub 2010 Aug 17.

37.

Introducing new strategies in...

Abbruzzese JL, Eggermont AM, Rubin EH.

Clin Cancer Res. 2010 Mar 1;16(5):1347. doi: 10.1158/1078-0432.CCR-10-0236. Epub 2010 Feb 23. No abstract available.

38.

Finding the right dose for cancer therapeutics--can we do better?

Rubin EH, Anderson KM.

Clin Cancer Res. 2010 Feb 15;16(4):1085-7. doi: 10.1158/1078-0432.CCR-09-3246. Epub 2010 Feb 9.

39.

A single supratherapeutic dose of vorinostat does not prolong the QTc interval in patients with advanced cancer.

Munster PN, Rubin EH, Van Belle S, Friedman E, Patterson JK, Van Dyck K, Li X, Comisar W, Chodakewitz JA, Wagner JA, Iwamoto M.

Clin Cancer Res. 2009 Nov 15;15(22):7077-84. doi: 10.1158/1078-0432.CCR-09-1214. Epub 2009 Nov 3.

40.

Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease: a randomized controlled trial.

Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Harris WS.

JAMA. 2009 Oct 21;302(15):1651-7. doi: 10.1001/jama.2009.1487.

41.

Phase I study of eribulin mesylate administered once every 21 days in patients with advanced solid tumors.

Tan AR, Rubin EH, Walton DC, Shuster DE, Wong YN, Fang F, Ashworth S, Rosen LS.

Clin Cancer Res. 2009 Jun 15;15(12):4213-9. doi: 10.1158/1078-0432.CCR-09-0360. Epub 2009 Jun 9.

42.

Treatment of depression after coronary artery bypass surgery: a randomized controlled trial.

Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Dávila-Román VG, Steinmeyer BC, Hogue CW Jr.

Arch Gen Psychiatry. 2009 Apr;66(4):387-96. doi: 10.1001/archgenpsychiatry.2009.7.

43.

Identification of phosphorylation sites of TOPORS and a role for serine 98 in the regulation of ubiquitin but not SUMO E3 ligase activity.

Park HJ, Zheng H, Kulkarni D, Kerrigan J, Pungaliya P, Saleem A, Rubin EH.

Biochemistry. 2008 Dec 30;47(52):13887-96. doi: 10.1021/bi801904q.

PMID:
19053840
44.

Pharmacokinetic/pharmacodynamic modeling and simulation of neutropenia during phase I development of liposome-entrapped paclitaxel.

Fetterly GJ, Grasela TH, Sherman JW, Dul JL, Grahn A, Lecomte D, Fiedler-Kelly J, Damjanov N, Fishman M, Kane MP, Rubin EH, Tan AR.

Clin Cancer Res. 2008 Sep 15;14(18):5856-63. doi: 10.1158/1078-0432.CCR-08-1046.

45.

Optimal modeling for phase I design of a two drug combination-results of a phase I study of cisplatin with 9-nitrocamptothecin.

Lee SJ, Gounder M, Rubin EH, Li JM, Gu Z, Thalasila A, Loyer E, Kudelka AP, Verschraegen CF.

Invest New Drugs. 2008 Dec;26(6):541-51. doi: 10.1007/s10637-008-9147-y. Epub 2008 Jul 4.

PMID:
18600301
46.

Sequential topoisomerase targeting and analysis of mechanisms of resistance to topotecan in patients with acute myelogenous leukemia.

Saraiya B, Gounder M, Dutta J, Saleem A, Collazo C, Zimmerman L, Nazar A, Gharibo M, Schaar D, Lin Y, Shih W, Aisner J, Strair RK, Rubin EH.

Anticancer Drugs. 2008 Apr;19(4):411-20. doi: 10.1097/CAD.0b013e3282f5218b.

PMID:
18454051
47.

Ubiquitination by TOPORS regulates the prostate tumor suppressor NKX3.1.

Guan B, Pungaliya P, Li X, Uquillas C, Mutton LN, Rubin EH, Bieberich CJ.

J Biol Chem. 2008 Feb 22;283(8):4834-40. Epub 2007 Dec 12.

48.

Effects of drug efflux proteins and topoisomerase I mutations on the camptothecin analogue gimatecan.

Gounder MK, Nazar AS, Saleem A, Pungaliya P, Kulkarni D, Versace R, Rubin EH.

Invest New Drugs. 2008 Jun;26(3):205-13. Epub 2007 Oct 18.

PMID:
17943230
49.

Phase I and pharmacokinetic study of imatinib mesylate (Gleevec) and gemcitabine in patients with refractory solid tumors.

Ali Y, Lin Y, Gharibo MM, Gounder MK, Stein MN, Lagattuta TF, Egorin MJ, Rubin EH, Poplin EA.

Clin Cancer Res. 2007 Oct 1;13(19):5876-82.

50.

TOPORS functions as a SUMO-1 E3 ligase for chromatin-modifying proteins.

Pungaliya P, Kulkarni D, Park HJ, Marshall H, Zheng H, Lackland H, Saleem A, Rubin EH.

J Proteome Res. 2007 Oct;6(10):3918-23. Epub 2007 Sep 6.

PMID:
17803295

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