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Larry Rubinstein
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Journal Articles

Safety, Antitumor Activity, and Biomarker Analysis in a Phase I Trial of the Once-daily Wee1 Inhibitor Adavosertib (AZD1775) in Patients with Advanced Solid Tumors

Naoko Takebe, Abdul Rafeh Naqash, Geraldine O'Sullivan Coyne, Shivaani Kummar, Khanh Do, Ashley Bruns, Lamin Juwara, Jennifer Zlott, Larry Rubinstein, Richard Piekarz, Elad Sharon, Howard Streicher, Arjun Mittra, Sarah B. Miller, Jiuping Ji, Deborah Wilsker, Robert J. Kinders, Ralph E. Parchment, Li Chen, Ting-Chia Chang, Biswajit Das, Ganesh Mugundu, James H. Doroshow, Alice P. Chen
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2021) 27 (14): 3834–3844.
https://doi.org/10.1158/1078-0432.CCR-21-0329
Published: 15 July 2021
View article titled, Safety, Antitumor Activity, and Biomarker Analysis in a Phase I Trial of the Once-daily Wee1 Inhibitor Adavosertib (AZD1775) in Patients with Advanced Solid Tumors
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Includes: Supplementary data
Journal Articles

The Challenge for Development of Valuable Immuno-oncology Biomarkers

Janice M. Mehnert, Arta M. Monjazeb, Johanna M.T. Beerthuijzen, Deborah Collyar, Larry Rubinstein, Lyndsay N. Harris
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (17): 4970–4979.
https://doi.org/10.1158/1078-0432.CCR-16-3063
Published: 31 August 2017
View article titled, The Challenge for Development of Valuable Immuno-oncology Biomarkers
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Journal Articles

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

Holly A. Massett, Grace Mishkin, Larry Rubinstein, S. Percy Ivy, Andrea Denicoff, Elizabeth Godwin, Kate DiPiazza, Jennifer Bolognese, James A. Zwiebel, Jeffrey S. Abrams
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (22): 5408–5416.
https://doi.org/10.1158/1078-0432.CCR-16-0338
Published: 14 November 2016
View article titled, Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual
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Journal Articles

Development of a quantitative enzyme immunoassay for measurement of PAR as a pharmacodynamic biomarker of PARP activity

Robert J. Kinders, Joann Palma, Xuesong Liu, Milagros Colon-Lopez, Yan Luo, Luiz E. Rodriguez, Yan Shi, Ran Guan, Shimin Wei, Jennifer Low, Anthony Murgo, Oxana Pickerel, Shivaani Kumar, Martin Gutierrez, Larry Rubinstein, Sherry Yang, Jay Ji, Gurmeet Kaur, Ralph Parchment, Tiziano DiPaolo, Jerry Collins, Melinda Hollingshead, Joseph Tomaszewski, James Doroshow, Vincent Giranda
Journal: Clinical Cancer Research
Clin Cancer Res (2006) 12 (19_Supplement): A5.
Published: 15 August 2014
View article titled, Development of a quantitative enzyme immunoassay for measurement of PAR as a pharmacodynamic biomarker of PARP activity
Journal Articles

Design of Phase I Combination Trials: Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee

Channing J. Paller, Penelope A. Bradbury, S. Percy Ivy, Lesley Seymour, Patricia M. LoRusso, Laurence Baker, Larry Rubinstein, Erich Huang, Deborah Collyar, Susan Groshen, Steven Reeves, Lee M. Ellis, Daniel J. Sargent, Gary L. Rosner, Michael L. LeBlanc, Mark J. Ratain
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (16): 4210–4217.
https://doi.org/10.1158/1078-0432.CCR-14-0521
Published: 13 August 2014
View article titled, Design of Phase I Combination Trials: Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee
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Journal Articles

Developing Safety Criteria for Introducing New Agents into Neoadjuvant Trials

Angela DeMichele, Donald A. Berry, JoAnne Zujewski, Sally Hunsberger, Larry Rubinstein, Joseph E. Tomaszewski, Gary Kelloff, Jane Perlmutter, Meredith Buxton, Julia Lyandres, Kathy S. Albain, Chris Benz, A. Jo Chien, Paul Haluska, Brian Leyland-Jones, Minetta C. Liu, Pamela Munster, Olufunmilayo Olopade, John W. Park, Barbara A. Parker, Lajos Pusztai, Debu Tripathy, Hope Rugo, Douglas Yee, Laura Esserman
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (11): 2817–2823.
https://doi.org/10.1158/1078-0432.CCR-12-2620
Published: 30 May 2013
View article titled, Developing Safety Criteria for Introducing New Agents into Neoadjuvant Trials
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Journal Articles

First-in-Human Phase 0 Trial of Oral 5-Iodo-2-Pyrimidinone-2′-Deoxyribose in Patients with Advanced Malignancies

Shivaani Kummar, Larry Anderson, Kimberly Hill, Eva Majerova, Deborah Allen, Yvonne Horneffer, S. Percy Ivy, Larry Rubinstein, Pamela Harris, James H. Doroshow, Jerry M. Collins
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (7): 1852–1857.
https://doi.org/10.1158/1078-0432.CCR-12-3118
Published: 02 April 2013
View article titled, First-in-Human Phase 0 Trial of Oral 5-Iodo-2-Pyrimidinone-2′-Deoxyribose in Patients with Advanced Malignancies
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Journal Articles

A Phase I Study of Veliparib in Combination with Metronomic Cyclophosphamide in Adults with Refractory Solid Tumors and Lymphomas

Shivaani Kummar, Jiuping Ji, Robert Morgan, Heinz-Josef Lenz, Shannon L. Puhalla, Chandra P. Belani, David R. Gandara, Deborah Allen, Brian Kiesel, Jan H. Beumer, Edward M. Newman, Larry Rubinstein, Alice Chen, Yiping Zhang, Lihua Wang, Robert J. Kinders, Ralph E. Parchment, Joseph E. Tomaszewski, James H. Doroshow
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (6): 1726–1734.
https://doi.org/10.1158/1078-0432.CCR-11-2821
Published: 14 March 2012
View article titled, A Phase I Study of Veliparib in Combination with Metronomic Cyclophosphamide in Adults with Refractory Solid Tumors and Lymphomas
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Includes: Supplementary data
Journal Articles

Development of a Validated Immunofluorescence Assay for γH2AX as a Pharmacodynamic Marker of Topoisomerase I Inhibitor Activity

Robert J. Kinders, Melinda Hollingshead, Scott Lawrence, Jiuping Ji, Brian Tabb, William M. Bonner, Yves Pommier, Larry Rubinstein, Yvonne A. Evrard, Ralph E. Parchment, Joseph Tomaszewski, James H. Doroshow
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (22): 5447–5457.
https://doi.org/10.1158/1078-0432.CCR-09-3076
Published: 14 November 2010
View article titled, Development of a Validated Immunofluorescence Assay for γH2AX as a Pharmacodynamic Marker of Topoisomerase I Inhibitor Activity
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Includes: Supplementary data
Journal Articles

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

S. Percy Ivy, Lillian L. Siu, Elizabeth Garrett-Mayer, Larry Rubinstein
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (6): 1726–1736.
https://doi.org/10.1158/1078-0432.CCR-09-1961
Published: 14 March 2010
View article titled, 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
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Journal Articles

The Design of Phase II Clinical Trials Testing Cancer Therapeutics: Consensus Recommendations from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee

Lesley Seymour, S. Percy Ivy, Daniel Sargent, David Spriggs, Laurence Baker, Larry Rubinstein, Mark J. Ratain, Michael Le Blanc, David Stewart, John Crowley, Susan Groshen, Jeffrey S. Humphrey, Pamela West, Donald Berry
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (6): 1764–1769.
https://doi.org/10.1158/1078-0432.CCR-09-3287
Published: 14 March 2010
View article titled, The Design of Phase II Clinical Trials Testing Cancer Therapeutics: Consensus Recommendations from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee
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Journal Articles

Monitoring Drug-Induced γH2AX as a Pharmacodynamic Biomarker in Individual Circulating Tumor Cells

Lihua H. Wang, Thomas D. Pfister, Ralph E. Parchment, Shivaani Kummar, Larry Rubinstein, Yvonne A. Evrard, Martin E. Gutierrez, Anthony J. Murgo, Joseph E. Tomaszewski, James H. Doroshow, Robert J. Kinders
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (3): 1073–1084.
https://doi.org/10.1158/1078-0432.CCR-09-2799
Published: 01 February 2010
View article titled, Monitoring Drug-Induced γH2AX as a Pharmacodynamic Biomarker in Individual Circulating Tumor Cells
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Includes: Supplementary data
Journal Articles

Randomized Phase II Designs

Larry Rubinstein, John Crowley, Percy Ivy, Michael LeBlanc, Dan Sargent
Journal: Clinical Cancer Research
Clin Cancer Res (2009) 15 (6): 1883–1890.
https://doi.org/10.1158/1078-0432.CCR-08-2031
Published: 16 March 2009
View article titled, Randomized Phase II Designs
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Journal Articles

Preclinical Modeling of a Phase 0 Clinical Trial: Qualification of a Pharmacodynamic Assay of Poly (ADP-Ribose) Polymerase in Tumor Biopsies of Mouse Xenografts

Robert J. Kinders, Melinda Hollingshead, Sonny Khin, Larry Rubinstein, Joseph E. Tomaszewski, James H. Doroshow, Ralph E. Parchment, the National Cancer Institute Phase 0 Clinical Trials Team
Journal: Clinical Cancer Research
Clin Cancer Res (2008) 14 (21): 6877–6885.
https://doi.org/10.1158/1078-0432.CCR-08-0214
Published: 03 November 2008
View article titled, Preclinical Modeling of a Phase 0 Clinical Trial: Qualification of a Pharmacodynamic Assay of Poly (ADP-Ribose) Polymerase in Tumor Biopsies of Mouse Xenografts
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Includes: Supplementary data
Journal Articles

Designing Phase 0 Cancer Clinical Trials

Anthony J. Murgo, Shivaani Kummar, Larry Rubinstein, Martin Gutierrez, Jerry Collins, Robert Kinders, Ralph E. Parchment, Jiuping Ji, Seth M. Steinberg, Sherry X. Yang, Melinda Hollingshead, Alice Chen, Lee Helman, Robert Wiltrout, Joseph E. Tomaszewski, James H. Doroshow
Journal: Clinical Cancer Research
Clin Cancer Res (2008) 14 (12): 3675–3682.
https://doi.org/10.1158/1078-0432.CCR-07-4560
Published: 16 June 2008
View article titled, Designing Phase 0 Cancer Clinical Trials
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