Larry Rubinstein

Larry Rubinstein

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Larry Rubinstein

Larry Rubinstein

Publications by authors named "Larry Rubinstein"

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

Clin Pharmacol Ther 2019 Oct 29;106(4):803-809. Epub 2019 Apr 29.

Investigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institute of Health, Rockville, Maryland, USA.

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http://dx.doi.org/10.1002/cpt.1442DOI Listing
October 2019

Exposure time versus cytotoxicity for anticancer agents.

Cancer Chemother Pharmacol 2019 Aug 17;84(2):359-371. Epub 2019 May 17.

Developmental Therapeutics Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD, 20852, USA.

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http://dx.doi.org/10.1007/s00280-019-03863-wDOI Listing
August 2019

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

Oncologist 2018 11 31;23(11):1269-e125. Epub 2018 May 31.

Early Clinical Trials Development Program, Developmental Therapeutics Clinic, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA

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http://theoncologist.alphamedpress.org/lookup/doi/10.1634/th
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http://dx.doi.org/10.1634/theoncologist.2018-0203DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6291327PMC
November 2018

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

Breast Cancer Res Treat 2018 Feb 8;168(1):35-41. Epub 2017 Nov 8.

Lombardi Comprehensive Cancer Center, MedStar Georgetown University Hospital, 3800 Reservoir Rd NW, Podium B Room 404, Washington, 20007, DC, USA.

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http://dx.doi.org/10.1007/s10549-017-4563-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5940334PMC
February 2018

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

Cancer Sci 2018 Jan 8;109(1):207-214. Epub 2017 Dec 8.

Investigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institute of Health, Rockville, MD, USA.

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http://doi.wiley.com/10.1111/cas.13436
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http://dx.doi.org/10.1111/cas.13436DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5765308PMC
January 2018

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

J Natl Cancer Inst Monogr 2017 11;2017(52)

Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD; National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD; Memorial Sloan Kettering Cancer Center, New York, NY; University of Kansas, Lawrence, KS; University of Florida, Gainsville, FL; Yale University, New Haven, CT; University of Iowa, Iowa City, IA; Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; University of Rochester Medical Center, Rochester, NY; Columbia University Medical Center, New York, NY; The University of Texas MD Anderson Cancer Center, Houston, TX; Peking University Cancer Hospital, Beijing, China; University of Pittsburgh, Pittsburgh, PA; Weill Cornell Medicine at Cornell University, New York, NY; Bastyr University, Kenmore, WA; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD; Tsinghua University, Beijing, China.

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http://dx.doi.org/10.1093/jncimonographs/lgx003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6061228PMC
November 2017

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

Cancer Med 2017 Aug 1;6(8):1952-1964. Epub 2017 Aug 1.

Molecular Pharmacology Group, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, Maryland, 21702.

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http://dx.doi.org/10.1002/cam4.1131DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5548882PMC
August 2017

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

Gastric Cancer 2017 May 10;20(3):481-488. Epub 2016 Aug 10.

Investigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Bethesda, MD, 20892, USA.

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http://dx.doi.org/10.1007/s10120-016-0629-xDOI Listing
May 2017

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

Semin Oncol 2016 08 14;43(4):446-52. Epub 2016 Jun 14.

National Cancer Institute, National Institutes of Health, Bethesda, MD.

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http://dx.doi.org/10.1053/j.seminoncol.2016.06.002DOI Listing
August 2016

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

Invest New Drugs 2015 Jun 1;33(3):720-8. Epub 2015 Feb 1.

Division of Cancer Treatment and Diagnosis, National Cancer Institute, 31 Center Drive, Bldg 31, Rm 3A44, Bethesda, MD, 20892, USA.

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http://dx.doi.org/10.1007/s10637-015-0212-zDOI Listing
June 2015

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

J Natl Cancer Inst 2015 Apr 6;107(4). Epub 2015 Feb 6.

Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (SK, ECP, APC, LVR, YZ, RMS, BAC, JHD); Applied/Developmental Research Directorate, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD (PMW, CJL).

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http://dx.doi.org/10.1093/jnci/djv003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4334817PMC
April 2015

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

J Hematol Oncol 2015 Feb 6;8. Epub 2015 Feb 6.

National Clinical Target Validation Laboratory, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD, 20892, USA.

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http://dx.doi.org/10.1186/s13045-014-0104-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4343190PMC
February 2015

Phase II design: history and evolution.

Authors:
Larry Rubinstein

Chin Clin Oncol 2014 Dec;3(4):48

Biometric Research Branch, NCI, Bethesda, MD, USA.

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http://dx.doi.org/10.3978/j.issn.2304-3865.2014.02.02DOI Listing
December 2014

Are we ready for the 10% solution?

Oncologist 2014 May 22;19(5):439-40. Epub 2014 Apr 22.

Cancer Therapy Evaluation Program, Biometric Research Branch, and Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA.

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http://theoncologist.alphamedpress.org/content/19/5/439.full
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http://theoncologist.alphamedpress.org/cgi/doi/10.1634/theon
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http://dx.doi.org/10.1634/theoncologist.2014-0126DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4012974PMC
May 2014

Response.

J Natl Cancer Inst 2013 Jul 30;105(13):993-4. Epub 2013 May 30.

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http://dx.doi.org/10.1093/jnci/djt126DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3708538PMC
July 2013

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

J Natl Cancer Inst 2012 Dec 19;104(24):1860-6. Epub 2012 Nov 19.

Karmanos Cancer Institute, Department of Oncology, Detroit, MI, USA.

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http://dx.doi.org/10.1093/jnci/djs439DOI Listing
December 2012

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

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

Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, USA.

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http://dx.doi.org/10.1177/1740774512450101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3598604PMC
August 2012

Poly(ADP-ribose) polymerase inhibition enhances p53-dependent and -independent DNA damage responses induced by DNA damaging agent.

Cell Cycle 2011 Dec 1;10(23):4074-82. Epub 2011 Dec 1.

Division of Cancer Treatment and Diagnosis, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.

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http://www.tandfonline.com/doi/abs/10.4161/cc.10.23.18170
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http://dx.doi.org/10.4161/cc.10.23.18170DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272289PMC
December 2011

Development of a validated immunofluorescence assay for γH2AX as a pharmacodynamic marker of topoisomerase I inhibitor activity.

Clin Cancer Res 2010 Nov 5;16(22):5447-57. Epub 2010 Oct 5.

Laboratory of Human Toxicology and Pharmacology, Applied/Developmental Research Support Directorate, Science Applications International Corporation-Frederick, Inc., NationalCancer Institute-Frederick, Frederick, MD 21702, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-09-3076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2982895PMC
November 2010

The statistics of phase 0 trials.

Stat Med 2010 May;29(10):1072-6

Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3902019PMC
http://dx.doi.org/10.1002/sim.3840DOI Listing
May 2010

Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee.

Clin Cancer Res 2010 Mar 9;16(6):1726-36. Epub 2010 Mar 9.

Investigational Drug Branch and Biometrics Research Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland 20852, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-09-1961DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5207802PMC
March 2010

Immunohistochemical detection of poly(ADP-ribose) polymerase inhibition by ABT-888 in patients with refractory solid tumors and lymphomas.

Cancer Biol Ther 2009 Nov 25;8(21):2004-9. Epub 2009 Nov 25.

Division of Cancer Treatment and Diagnosis, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD, USA.

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http://dx.doi.org/10.4161/cbt.8.21.9917DOI Listing
November 2009

Randomized phase II designs.

Clin Cancer Res 2009 Mar 10;15(6):1883-90. Epub 2009 Mar 10.

National Cancer Institute, Bethesda, Maryland, USA.

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http://clincancerres.aacrjournals.org/cgi/doi/10.1158/1078-0
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http://dx.doi.org/10.1158/1078-0432.CCR-08-2031DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3774021PMC
March 2009

Individual patient data analysis to assess modifications to the RECIST criteria.

Eur J Cancer 2009 Jan 16;45(2):248-60. Epub 2008 Dec 16.

European Organization for Research and Treatment of Cancer Headquarters, Avenue Mounierlaan 83/11, Brussels, Belgium.

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http://dx.doi.org/10.1016/j.ejca.2008.10.027DOI Listing
January 2009

Preclinical modeling of a phase 0 clinical trial: qualification of a pharmacodynamic assay of poly (ADP-ribose) polymerase in tumor biopsies of mouse xenografts.

Clin Cancer Res 2008 Nov;14(21):6877-85

Laboratory of Human Toxicology and Pharmacology, Applied/Developmental Research Support Directorate, Science Applications International Corporation-Frederick, Inc., National Cancer Institute-Frederick, Frederick, MD 21702, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-08-0214DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2766769PMC
November 2008

Phase 0 clinical trials: conceptions and misconceptions.

Cancer J 2008 May-Jun;14(3):133-7

Center for Cancer Research, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland 20892, USA.

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http://dx.doi.org/10.1097/PPO.0b013e318172d6f3DOI Listing
September 2008

Designing phase 0 cancer clinical trials.

Clin Cancer Res 2008 Jun;14(12):3675-82

Division of Cancer Treatment and Diagnosis and Center for Cancer Research, National Cancer Institute, Bethesda, Maryland 20892-2440, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-07-4560DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2435428PMC
June 2008

Phase 0 clinical trials in cancer drug development: from FDA guidance to clinical practice.

Mol Interv 2007 Dec;7(6):325-34

Laboratory of Human Toxicology and Pharmacology, Applied/Developmental Research Support Directorate, SAIC-Frederick Inc., NCI-Frederick, Frederick, Maryland 21702, USA.

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http://dx.doi.org/10.1124/mi.7.6.9DOI Listing
December 2007

Risks and benefits of phase 1 oncology trials, 1991 through 2002.

N Engl J Med 2005 Mar;352(9):895-904

Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Md 20892-1156, USA.

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http://dx.doi.org/10.1056/NEJMsa042220DOI Listing
March 2005