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Gary L. Rosner
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Journal Articles

Phase I and Pharmacokinetic Study of Romidepsin in Patients with Cancer and Hepatic Dysfunction: A National Cancer Institute Organ Dysfunction Working Group Study

Roisin M. Connolly, Eric Laille, Ulka Vaishampayan, Vincent Chung, Karen Kelly, Afshin Dowlati, Olatunji B. Alese, R. Donald Harvey, Paul Haluska, Lillian L. Siu, Shivaani Kummar, Richard Piekarz, S. Percy Ivy, Nicole M. Anders, Melinda Downs, Ashley O'Connor, Angela Scardina, Jacqueline Saunders, Gary L. Rosner, Michael A. Carducci, Michelle A. Rudek
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (20): 5329–5337.
https://doi.org/10.1158/1078-0432.CCR-20-1412
Published: 15 October 2020
View article titled, Phase I and Pharmacokinetic Study of Romidepsin in Patients with Cancer and Hepatic Dysfunction: A National Cancer Institute Organ Dysfunction Working Group Study
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Journal Articles

Muscadine Grape Skin Extract (MPX) in Men with Biochemically Recurrent Prostate Cancer: A Randomized, Multicenter, Placebo-Controlled Clinical Trial

Channing J. Paller, Xian C. Zhou, Elisabeth I. Heath, Mary-Ellen Taplin, Tina Mayer, Mark N. Stein, Glenn J. Bubley, Roberto Pili, Tamaro Hudson, Radhika Kakarla, Muneer M. Abbas, Nicole M. Anders, Donna Dowling, Serina King, Ashley B. Bruns, William D. Wagner, Charles G. Drake, Emmanuel S. Antonarakis, Mario A. Eisenberger, Samuel R. Denmeade, Michelle A. Rudek, Gary L. Rosner, Michael A. Carducci
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (2): 306–315.
https://doi.org/10.1158/1078-0432.CCR-17-1100
Published: 15 January 2018
View article titled, Muscadine Grape Skin Extract (MPX) in Men with Biochemically Recurrent Prostate Cancer: A Randomized, Multicenter, Placebo-Controlled Clinical Trial
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Includes: Supplementary data
Journal Articles

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

Daphne Day, Arta M. Monjazeb, Elad Sharon, S. Percy Ivy, Eric H. Rubin, Gary L. Rosner, Marcus O. Butler
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (17): 4980–4991.
https://doi.org/10.1158/1078-0432.CCR-16-3064
Published: 31 August 2017
View article titled, From Famine to Feast: Developing Early-Phase Combination Immunotherapy Trials Wisely
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Journal Articles

Challenges and Opportunities in Adapting Clinical Trial Design for Immunotherapies

Lillian L. Siu, S. Percy Ivy, Erica L. Dixon, Amy E. Gravell, Steven A. Reeves, Gary L. Rosner
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (17): 4950–4958.
https://doi.org/10.1158/1078-0432.CCR-16-3079
Published: 31 August 2017
View article titled, Challenges and Opportunities in Adapting Clinical Trial Design for Immunotherapies
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Journal Articles

Individualized Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of Molecular Profiling of Tissue and Blood in Metastatic Triple-Negative Breast Cancer

Heather A. Parsons, Julia A. Beaver, Ashley Cimino-Mathews, Siraj M. Ali, Jennifer Axilbund, David Chu, Roisin M. Connolly, Rory L. Cochran, Sarah Croessmann, Travis A. Clark, Christopher D. Gocke, Stacie C. Jeter, Mark R. Kennedy, Josh Lauring, Justin Lee, Doron Lipson, Vincent A. Miller, Geoff A. Otto, Gary L. Rosner, Jeffrey S. Ross, Shannon Slater, Philip J. Stephens, Dustin A. VanDenBerg, Antonio C. Wolff, Lauren E. Young, Daniel J. Zabransky, Zhe Zhang, Jane Zorzi, Vered Stearns, Ben H. Park
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (2): 379–386.
https://doi.org/10.1158/1078-0432.CCR-16-1543
Published: 15 January 2017
View article titled, Individualized Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of Molecular Profiling of Tissue and Blood in Metastatic Triple-Negative Breast Cancer
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Includes: Supplementary data
Journal Articles

Impact of the 2010 Consensus Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee

Lesley Seymour, Susan Groshen, Gary L. Rosner, Daniel M. Sullivan, David R. Spriggs, Steven Reeves, Amy Gravell, S. Percy Ivy, Mark J. Ratain
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (22): 5057–5063.
https://doi.org/10.1158/1078-0432.CCR-15-0035
Published: 12 November 2015
View article titled, Impact of the 2010 Consensus Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee
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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

A Comparison of the Pharmacokinetics and Pharmacodynamics of Docetaxel between African-American and Caucasian Cancer Patients: CALGB 9871

Lionel D. Lewis, Antonius A. Miller, Gary L. Rosner, Jonathan E. Dowell, Manuel Valdivieso, Mary V. Relling, Merrill J. Egorin, Robert R. Bies, Donna R. Hollis, Ellis G. Levine, Gregory A. Otterson, Frederick Millard, Mark J. Ratain, for the Cancer and Leukemia Group B
Journal: Clinical Cancer Research
Clin Cancer Res (2007) 13 (11): 3302–3311.
https://doi.org/10.1158/1078-0432.CCR-06-2345
Published: 01 June 2007
View article titled, A Comparison of the Pharmacokinetics and Pharmacodynamics of Docetaxel between African-American and Caucasian Cancer Patients: CALGB 9871
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Journal Articles

Prospective Evaluation of Body Surface Area as a Determinant of Paclitaxel Pharmacokinetics and Pharmacodynamics in Women with Solid Tumors: Cancer and Leukemia Group B Study 9763

Antonius A. Miller, Gary L. Rosner, Merrill J. Egorin, Donna Hollis, Stuart M. Lichtman, Mark J. Ratain, for the Cancer and Leukemia Group B
Journal: Clinical Cancer Research
Clin Cancer Res (2004) 10 (24): 8325–8331.
https://doi.org/10.1158/1078-0432.CCR-04-1078
Published: 28 December 2004
View article titled, Prospective Evaluation of Body Surface Area as a Determinant of Paclitaxel Pharmacokinetics and Pharmacodynamics in Women with Solid Tumors: <subtitle>Cancer and Leukemia Group B Study 9763</subtitle>
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Journal Articles

Phase I Evaluation of Prolonged-infusion Gemcitabine with Fludarabine for Relapsed or Refractory Acute Myelogenous Leukemia

David A. Rizzieri, Valerie K. Ibom, Joseph O. Moore, Carlos M. DeCastro, Gary L. Rosner, David J. Adams, Traci Foster, Nancy Payne, Maria Thompson, James J. Vredenburgh, Christina Gasparetto, Gwynn D. Long, Nelson J. Chao, Jon P. Gockerman
Journal: Clinical Cancer Research
Clin Cancer Res (2003) 9 (2): 663–668.
Published: 01 February 2003
View article titled, Phase I Evaluation of Prolonged-infusion Gemcitabine with Fludarabine for Relapsed or Refractory Acute Myelogenous Leukemia
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Journal Articles

A Phase I Trial of Escalating Doses of Trastuzumab Combined with Daily Subcutaneous Interleukin 2: Report of Cancer and Leukemia Group B 9661

Gini F. Fleming, Neal J. Meropol, Gary L. Rosner, Donna R. Hollis, William E. Carson, III, Michael Caligiuri, Joanne Mortimer, Katherine Tkaczuk, Robin Parihar, Richard L. Schilsky, Mark J. Ratain
Journal: Clinical Cancer Research
Clin Cancer Res (2002) 8 (12): 3718–3727.
Published: 01 December 2002
View article titled, A Phase I Trial of Escalating Doses of Trastuzumab Combined with Daily Subcutaneous Interleukin 2: <subtitle>Report of Cancer and Leukemia Group B 9661</subtitle>
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