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A Phase I Pharmacokinetic Study of Belinostat in Patients with Advanced Cancers and Varying Degrees of Liver Dysfunction.

Takebe N, Beumer JH, Kummar S, Kiesel BF, Dowlati A, O'Sullivan Coyne G, Piekarz R, Rubinstein L, Fogli LK, Vaishampayan U, Goel S, O'Bryant CL, El-Rayes BF, Chung V, Lenz HJ, Kim R, Belani CP, Tuscano JM, Schelman W, Moore N, Doroshow JH, Chen AP.

Br J Clin Pharmacol. 2019 Jul 4. doi: 10.1111/bcp.14054. [Epub ahead of print]


Factors Affecting Combination Trial Success (FACTS): Investigator Survey Results on Early-Phase Combination Trials.

Paller CJ, Huang EP, Luechtefeld T, Massett HA, Williams CC, Zhao J, Gravell AE, Tamashiro T, Reeves SA, Rosner GL, Carducci MA, Rubinstein L, Ivy SP.

Front Med (Lausanne). 2019 Jun 4;6:122. doi: 10.3389/fmed.2019.00122. eCollection 2019.


Exposure time versus cytotoxicity for anticancer agents.

Evans DM, Fang J, Silvers T, Delosh R, Laudeman J, Ogle C, Reinhart R, Selby M, Bowles L, Connelly J, Harris E, Krushkal J, Rubinstein L, Doroshow JH, Teicher BA.

Cancer Chemother Pharmacol. 2019 Aug;84(2):359-371. doi: 10.1007/s00280-019-03863-w. Epub 2019 May 17.


STI Foundation (STIF): latest developments and the future.

Rubinstein L, Grundy-Bowers M.

Sex Transm Infect. 2019 May;95(3):162. doi: 10.1136/sextrans-2018-053820. No abstract available.


A Comparative Study of Longitudinal Toxicities of Cytotoxic Drugs, Molecularly Targeted Agents, Immunomodulatory Drugs, and Cancer Vaccines.

Hirakawa A, Sudo K, Yonemori K, Sadachi R, Kinoshita F, Kobayashi Y, Okuma HS, Kawachi A, Tamura K, Fujiwara Y, Rubinstein L, Takebe N.

Clin Pharmacol Ther. 2019 Mar 30. doi: 10.1002/cpt.1442. [Epub ahead of print]


Molecular and pathologic characterization of AML with double Inv(3)(q21q26.2).

Hodge JC, Bosler D, Rubinstein L, Sadri N, Shetty S.

Cancer Genet. 2019 Jan;230:28-36. doi: 10.1016/j.cancergen.2018.08.007. Epub 2018 Nov 16. Review.


Virus Reduction Neutralization Test: A Single-Cell Imaging High-Throughput Virus Neutralization Assay for Dengue.

Whiteman MC, Bogardus L, Giacone DG, Rubinstein LJ, Antonello JM, Sun D, Daijogo S, Gurney KB.

Am J Trop Med Hyg. 2018 Dec;99(6):1430-1439. doi: 10.4269/ajtmh.17-0948.


What Can Be Done to Improve Research Biopsy Quality in Oncology Clinical Trials?

Ferry-Galow KV, Datta V, Makhlouf HR, Wright J, Wood BJ, Levy E, Pisano ED, Tam AL, Lee SI, Mahmood U, Rubinstein LV, Doroshow JH, Chen AP.

J Oncol Pract. 2018 Oct 4:JOP1800092. doi: 10.1200/JOP.18.00092. [Epub ahead of print]


National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer.

Seidman AD, Bordeleau L, Fehrenbacher L, Barlow WE, Perlmutter J, Rubinstein L, Wedam SB, Hershman DL, Hayes JF, Butler LP, Smith ML, Regan MM, Beaver JA, Amiri-Kordestani L, Rastogi P, Zujewski JA, Korde LA.

J Clin Oncol. 2018 Sep 13:JCO1800242. doi: 10.1200/JCO.18.00242. [Epub ahead of print]


A Phase I Study of Ganetespib and Ziv-Aflibercept in Patients with Advanced Carcinomas and Sarcomas.

Meehan R, Kummar S, Do K, O'Sullivan Coyne G, Juwara L, Zlott J, Rubinstein L, Doroshow JH, Chen AP.

Oncologist. 2018 Nov;23(11):1269-e125. doi: 10.1634/theoncologist.2018-0203. Epub 2018 May 31.


BASHH/BHIVA mentoring scheme.

Rubinstein L, Fox E.

Sex Transm Infect. 2018 Jun;94(4):239. doi: 10.1136/sextrans-2018-053608. No abstract available.


Adjuvant continuous metronomic adriamycin + cyclophosphamide followed by weekly nab-paclitaxel for high-risk early-stage breast cancer.

Cho E, Wu Q, Rubinstein L, Linden H, Gralow J, Specht J, Gadi V, Ellis G.

Breast J. 2018 Jul;24(4):610-614. doi: 10.1111/tbj.13013. Epub 2018 Mar 13.


State of the Science: Cancer Complementary and Alternative Medicine Therapeutics Research-NCI Strategic Workshop Highlights of Discussion Report.

Xi D, Bao T, Chen Q, Chen S, Cheng YC, Cullen J, Frank DA, Friedberg JW, Kronish I, Lee JE, Levine M, Li P, Li S, Lu W, Mao JJ, O'Keefe S, Rubinstein L, Shah MA, Standish L, Paller CJ, Chu E.

J Natl Cancer Inst Monogr. 2017 Nov 1;2017(52). doi: 10.1093/jncimonographs/lgx003.


Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials.

Lynce F, Blackburn MJ, Cai L, Wang H, Rubinstein L, Harris P, Isaacs C, Pohlmann PR.

Breast Cancer Res Treat. 2018 Feb;168(1):35-41. doi: 10.1007/s10549-017-4563-3. Epub 2017 Nov 8.


The evolutionarily conserved factor Sus1/ENY2 plays a role in telomere length maintenance.

Galán A, García-Oliver E, Nuño-Cabanes C, Rubinstein L, Kupiec M, Rodríguez-Navarro S.

Curr Genet. 2018 Jun;64(3):635-644. doi: 10.1007/s00294-017-0778-4. Epub 2017 Nov 7.


Potential utility of a longitudinal relative dose intensity of molecularly targeted agents in phase 1 dose-finding trials.

Hirakawa A, Yonemori K, Kinoshita F, Kobayashi Y, Okuma HS, Kawachi A, Tamura K, Fujiwara Y, Rubinstein L, Harris PJ, Takebe N.

Cancer Sci. 2018 Jan;109(1):207-214. doi: 10.1111/cas.13436. Epub 2017 Dec 8.


The Challenge for Development of Valuable Immuno-oncology Biomarkers.

Mehnert JM, Monjazeb AM, Beerthuijzen JMT, Collyar D, Rubinstein L, Harris LN.

Clin Cancer Res. 2017 Sep 1;23(17):4970-4979. doi: 10.1158/1078-0432.CCR-16-3063.


First-in-human study of the epichaperome inhibitor PU-H71: clinical results and metabolic profile.

Speranza G, Anderson L, Chen AP, Do K, Eugeni M, Weil M, Rubinstein L, Majerova E, Collins J, Horneffer Y, Juwara L, Zlott J, Bishop R, Conley BA, Streicher H, Tomaszewski J, Doroshow JH, Kummar S.

Invest New Drugs. 2018 Apr;36(2):230-239. doi: 10.1007/s10637-017-0495-3. Epub 2017 Aug 12.


Small cell lung carcinoma cell line screen of etoposide/carboplatin plus a third agent.

Teicher BA, Silvers T, Selby M, Delosh R, Laudeman J, Ogle C, Reinhart R, Parchment R, Krushkal J, Sonkin D, Rubinstein L, Morris J, Evans D.

Cancer Med. 2017 Aug;6(8):1952-1964. doi: 10.1002/cam4.1131. Epub 2017 Aug 1.


CREATE-X a role for capecitabine in early-stage breast cancer: an analysis of available data.

Zujewski JA, Rubinstein L.

NPJ Breast Cancer. 2017 Jul 20;3:27. doi: 10.1038/s41523-017-0029-3. eCollection 2017. Review.



Shalev A, Weil G, Rubinstein L.

Harefuah. 2016 Dec;155(12):762-766. Hebrew.


The National Cancer Institute ALMANAC: A Comprehensive Screening Resource for the Detection of Anticancer Drug Pairs with Enhanced Therapeutic Activity.

Holbeck SL, Camalier R, Crowell JA, Govindharajulu JP, Hollingshead M, Anderson LW, Polley E, Rubinstein L, Srivastava A, Wilsker D, Collins JM, Doroshow JH.

Cancer Res. 2017 Jul 1;77(13):3564-3576. doi: 10.1158/0008-5472.CAN-17-0489. Epub 2017 Apr 26.


Establishing proof of mechanism: Assessing target modulation in early-phase clinical trials.

Kummar S, Do K, Coyne GO, Chen A, Ji J, Rubinstein L, Doroshow JH.

Semin Oncol. 2016 Aug;43(4):446-52. doi: 10.1053/j.seminoncol.2016.06.002. Epub 2016 Jun 14. Review.


Analysis of esophagogastric cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase 1 trials.

Bando H, Rubinstein L, Harris P, Yoshino T, Doi T, Ohtsu A, Welch J, Takebe N.

Gastric Cancer. 2017 May;20(3):481-488. doi: 10.1007/s10120-016-0629-x. Epub 2016 Aug 10.


Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual.

Massett HA, Mishkin G, Rubinstein L, Ivy SP, Denicoff A, Godwin E, DiPiazza K, Bolognese J, Zwiebel JA, Abrams JS.

Clin Cancer Res. 2016 Nov 15;22(22):5408-5416. doi: 10.1158/1078-0432.CCR-16-0338. Epub 2016 Jul 11. Review.


Clinical and pharmacologic evaluation of two dosing schedules of indotecan (LMP400), a novel indenoisoquinoline, in patients with advanced solid tumors.

Kummar S, Chen A, Gutierrez M, Pfister TD, Wang L, Redon C, Bonner WM, Yutzy W, Zhang Y, Kinders RJ, Ji J, Allen D, Covey JM, Eiseman JL, Holleran JL, Beumer JH, Rubinstein L, Collins J, Tomaszewski J, Parchment R, Pommier Y, Doroshow JH.

Cancer Chemother Pharmacol. 2016 Jul;78(1):73-81. doi: 10.1007/s00280-016-2998-6. Epub 2016 May 11.


Creating clinical trial designs that incorporate clinical outcome assessments.

Gilbert MR, Rubinstein L, Lesser G.

Neuro Oncol. 2016 Mar;18 Suppl 2:ii21-ii25. doi: 10.1093/neuonc/nov254. Review.


Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of the Poly(ADP-ribose) Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Combination with Irinotecan in Patients with Advanced Solid Tumors.

LoRusso PM, Li J, Burger A, Heilbrun LK, Sausville EA, Boerner SA, Smith D, Pilat MJ, Zhang J, Tolaney SM, Cleary JM, Chen AP, Rubinstein L, Boerner JL, Bowditch A, Cai D, Bell T, Wolanski A, Marrero AM, Zhang Y, Ji J, Ferry-Galow K, Kinders RJ, Parchment RE, Shapiro GI.

Clin Cancer Res. 2016 Jul 1;22(13):3227-37. doi: 10.1158/1078-0432.CCR-15-0652. Epub 2016 Feb 3.


Analytical Validation and Application of a Targeted Next-Generation Sequencing Mutation-Detection Assay for Use in Treatment Assignment in the NCI-MPACT Trial.

Lih CJ, Sims DJ, Harrington RD, Polley EC, Zhao Y, Mehaffey MG, Forbes TD, Das B, Walsh WD, Datta V, Harper KN, Bouk CH, Rubinstein LV, Simon RM, Conley BA, Chen AP, Kummar S, Doroshow JH, Williams PM.

J Mol Diagn. 2016 Jan;18(1):51-67. doi: 10.1016/j.jmoldx.2015.07.006. Epub 2015 Nov 18.


Adjuvant Metronomic CMF in a Contemporary Breast Cancer Cohort: What's Old Is New.

Cho E, Schwemm AK, Rubinstein LM, Stevenson PA, Gooley TA, Ellis GK, Specht JM, Livingston RB, Linden HM, Gadi VK.

Clin Breast Cancer. 2015 Oct;15(5):e277-85. doi: 10.1016/j.clbc.2015.04.002. Epub 2015 Apr 24.


GeneMed: An Informatics Hub for the Coordination of Next-Generation Sequencing Studies that Support Precision Oncology Clinical Trials.

Zhao Y, Polley EC, Li MC, Lih CJ, Palmisano A, Sims DJ, Rubinstein LV, Conley BA, Chen AP, Williams PM, Kummar S, Doroshow JH, Simon RM.

Cancer Inform. 2015 Mar 19;14(Suppl 2):45-55. doi: 10.4137/CIN.S17282. eCollection 2015. Review.


Phase II design: history and evolution.

Rubinstein L.

Chin Clin Oncol. 2014 Dec;3(4):48. doi: 10.3978/j.issn.2304-3865.2014.02.02.


Application of molecular profiling in clinical trials for advanced metastatic cancers.

Kummar S, Williams PM, Lih CJ, Polley EC, Chen AP, Rubinstein LV, Zhao Y, Simon RM, Conley BA, Doroshow JH.

J Natl Cancer Inst. 2015 Feb 6;107(4). pii: djv003. doi: 10.1093/jnci/djv003. Print 2015 Apr.


Notch1 phenotype and clinical stage progression in non-small cell lung cancer.

Nguyen D, Rubinstein L, Takebe N, Miele L, Tomaszewski JE, Ivy P, Doroshow JH, Yang SX.

J Hematol Oncol. 2015 Feb 6;8:9. doi: 10.1186/s13045-014-0104-2.


The use of stereotactic radiosurgery for brain metastases from breast cancer: who benefits most?

Cho E, Rubinstein L, Stevenson P, Gooley T, Philips M, Halasz LM, Gensheimer MF, Linden HM, Rockhill JK, Gadi VK.

Breast Cancer Res Treat. 2015 Feb;149(3):743-9. doi: 10.1007/s10549-014-3242-x. Epub 2015 Feb 1.


Biomarker-driven phase 2 study of MK-2206 and selumetinib (AZD6244, ARRY-142886) in patients with colorectal cancer.

Do K, Speranza G, Bishop R, Khin S, Rubinstein L, Kinders RJ, Datiles M, Eugeni M, Lam MH, Doyle LA, Doroshow JH, Kummar S.

Invest New Drugs. 2015 Jun;33(3):720-8. doi: 10.1007/s10637-015-0212-z. Epub 2015 Feb 1.


Design of phase I combination trials: recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee.

Paller CJ, Bradbury PA, Ivy SP, Seymour L, LoRusso PM, Baker L, Rubinstein L, Huang E, Collyar D, Groshen S, Reeves S, Ellis LM, Sargent DJ, Rosner GL, LeBlanc ML, Ratain MJ.

Clin Cancer Res. 2014 Aug 15;20(16):4210-7. doi: 10.1158/1078-0432.CCR-14-0521. Review.


Historical controls for metastatic pancreatic cancer: benchmarks for planning and analyzing single-arm phase II trials.

Philip PA, Chansky K, LeBlanc M, Rubinstein L, Seymour L, Ivy SP, Alberts SR, Catalano PJ, Crowley J.

Clin Cancer Res. 2014 Aug 15;20(16):4176-85. doi: 10.1158/1078-0432.CCR-13-2024. Epub 2014 Jun 9.


Are we ready for the 10% solution?

Chen HX, Rubinstein LV, Shankar LK, Abrams JS.

Oncologist. 2014 May;19(5):439-40. doi: 10.1634/theoncologist.2014-0126. Epub 2014 Apr 22. No abstract available.


Telomere length kinetics assay (TELKA) sorts the telomere length maintenance (tlm) mutants into functional groups.

Rubinstein L, Ungar L, Harari Y, Babin V, Ben-Aroya S, Merenyi G, Marjavaara L, Chabes A, Kupiec M.

Nucleic Acids Res. 2014 Jun;42(10):6314-25. doi: 10.1093/nar/gku267. Epub 2014 Apr 11.


Environmental stresses disrupt telomere length homeostasis.

Romano GH, Harari Y, Yehuda T, Podhorzer A, Rubinstein L, Shamir R, Gottlieb A, Silberberg Y, Pe'er D, Ruppin E, Sharan R, Kupiec M.

PLoS Genet. 2013;9(9):e1003721. doi: 10.1371/journal.pgen.1003721. Epub 2013 Sep 5.



Hunsberger S, Rubinstein L, Boerner SA, LoRusso P.

J Natl Cancer Inst. 2013 Jul 3;105(13):993-4. doi: 10.1093/jnci/djt126. Epub 2013 May 30. No abstract available.


Developing safety criteria for introducing new agents into neoadjuvant trials.

DeMichele A, Berry DA, Zujewski J, Hunsberger S, Rubinstein L, Tomaszewski JE, Kelloff G, Perlmutter J, Buxton M, Lyandres J, Albain KS, Benz C, Chien AJ, Haluska P, Leyland-Jones B, Liu MC, Munster P, Olopade O, Park JW, Parker BA, Pusztai L, Tripathy D, Rugo H, Yee D, Esserman L.

Clin Cancer Res. 2013 Jun 1;19(11):2817-23. doi: 10.1158/1078-0432.CCR-12-2620. Epub 2013 Mar 7. Review.


Similar efficacy for phase I trials in comparison with DTIC for advanced malignant melanoma: an analysis of melanoma outcomes in CTEP-sponsored phase I trials 1995-2011.

Luke JJ, Rubinstein LV, Smith GL, Ivy SP, Harris PJ.

Melanoma Res. 2013 Apr;23(2):152-8. doi: 10.1097/CMR.0b013e32835f73b2.


First-in-human phase 0 trial of oral 5-iodo-2-pyrimidinone-2'-deoxyribose in patients with advanced malignancies.

Kummar S, Anderson L, Hill K, Majerova E, Allen D, Horneffer Y, Ivy SP, Rubinstein L, Harris P, Doroshow JH, Collins JM.

Clin Cancer Res. 2013 Apr 1;19(7):1852-7. doi: 10.1158/1078-0432.CCR-12-3118. Epub 2013 Feb 12.


Meta-analysis of the relationship between dose and benefit in phase I targeted agent trials.

Gupta S, Hunsberger S, Boerner SA, Rubinstein L, Royds R, Ivy P, LoRusso P.

J Natl Cancer Inst. 2012 Dec 19;104(24):1860-6. doi: 10.1093/jnci/djs439. Epub 2012 Nov 19.


Bacille Calmette-Guerin disease following Bacille Calmette-Guerin vaccination of an HIV-infected health-care worker.

Vera JH, Hill SC, Rubinstein L.

Int J STD AIDS. 2012 Jul;23(7):e1-2. doi: 10.1258/ijsa.2009.009393.


A method for utilizing co-primary efficacy outcome measures to screen regimens for activity in two-stage Phase II clinical trials.

Sill MW, Rubinstein L, Litwin S, Yothers G.

Clin Trials. 2012 Aug;9(4):385-95. doi: 10.1177/1740774512450101. Epub 2012 Jul 18.


A phase I study of veliparib in combination with metronomic cyclophosphamide in adults with refractory solid tumors and lymphomas.

Kummar S, Ji J, Morgan R, Lenz HJ, Puhalla SL, Belani CP, Gandara DR, Allen D, Kiesel B, Beumer JH, Newman EM, Rubinstein L, Chen A, Zhang Y, Wang L, Kinders RJ, Parchment RE, Tomaszewski JE, Doroshow JH.

Clin Cancer Res. 2012 Mar 15;18(6):1726-34. doi: 10.1158/1078-0432.CCR-11-2821. Epub 2012 Feb 3.


An anti-checkpoint activity for rif1.

Harari Y, Rubinstein L, Kupiec M.

PLoS Genet. 2011 Dec;7(12):e1002421. doi: 10.1371/journal.pgen.1002421. Epub 2011 Dec 15. No abstract available.

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