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Journal Articles

The New NCI Precision Medicine Trials

Lyndsay N. Harris, Charles D. Blanke, Harry P. Erba, James M. Ford, Robert J. Gray, Michael L. LeBlanc, Siwen Hu-Lieskovan, Mark R. Litzow, Selina M. Luger, Funda Meric-Bernstam, Peter J. O'Dwyer, Megan K.D. Othus, Katerina Politi, Lois E. Shepherd, Carmen J. Allegra, Helen X. Chen, S. Percy Ivy, Larissa A. Korde, Richard F. Little, Lisa M. McShane, Jeffrey A. Moscow, David R. Patton, Magdalena Thurin, Laura M. Yee, James H. Doroshow
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (23): 4728–4732.
https://doi.org/10.1158/1078-0432.CCR-23-0917
Published: 01 December 2023
View article titled, The New NCI Precision Medicine Trials
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Journal Articles

Randomized Phase II Trial of Sunitinib or Cediranib in Alveolar Soft Part Sarcoma

James Nguyen, Naoko Takebe, Shivaani Kummar, Albiruni Razak, Sant P. Chawla, Suzanne George, Shreyaskumar R. Patel, Mary Louise Keohan, Sujana Movva, Geraldine O'Sullivan Coyne, Khanh Do, Lamin Juwara, Brooke Augustine, Seth M. Steinberg, Laura Kuhlmann, S. Percy Ivy, James H. Doroshow, Alice P. Chen
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (7): 1200–1208.
https://doi.org/10.1158/1078-0432.CCR-22-2145
Published: 03 April 2023
View article titled, Randomized Phase II Trial of Sunitinib or Cediranib in Alveolar Soft Part Sarcoma
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Journal Articles

Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO–Friends of Cancer Research Joint Research Statement

Edward S. Kim, Thomas S. Uldrick, Caroline Schenkel, Suanna S. Bruinooge, R. Donald Harvey, Allison Magnuson, Alexander Spira, James L. Wade, Mark D. Stewart, Diana Merino Vega, Julia A. Beaver, Andrea M. Denicoff, Gwynn Ison, S. Percy Ivy, Suzanne George, Raymond P. Perez, Patricia A. Spears, William D. Tap, Richard L. Schilsky
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (9): 2394–2399.
https://doi.org/10.1158/1078-0432.CCR-20-3852
Published: 01 May 2021
View article titled, Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO–Friends of Cancer Research Joint Research Statement
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Journal Articles

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Washout Period and Concomitant Medication Work Group

R. Donald Harvey, Kathryn F. Mileham, Vishal Bhatnagar, Jamie R. Brewer, Atiqur Rahman, Cassadie Moravek, Andrew S. Kennedy, Elizabeth A. Ness, E. Claire Dees, S. Percy Ivy, Scot W. Ebbinghaus, Caroline Schenkel, Thomas S. Uldrick
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (9): 2400–2407.
https://doi.org/10.1158/1078-0432.CCR-20-3855
Published: 01 May 2021
View article titled, Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Washout Period and Concomitant Medication Work Group
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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

Transforming the Early Drug Development Paradigm at the National Cancer Institute: The Formation of NCI's Experimental Therapeutics Clinical Trials Network (ETCTN)

Holly A. Massett, Grace Mishkin, Jeffrey A. Moscow, Amy Gravell, Michael Steketee, Martha Kruhm, Sae H. Han, Barbara Barry, Michael Montello, James Zwiebel, Jeffrey S. Abrams, James H. Doroshow, S. Percy Ivy
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (23): 6925–6931.
https://doi.org/10.1158/1078-0432.CCR-19-1754
Published: 02 December 2019
View article titled, Transforming the Early Drug Development Paradigm at the National Cancer Institute: The Formation of NCI's Experimental Therapeutics Clinical Trials Network (ETCTN)
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Journal Articles

The HRD Decision—Which PARP Inhibitor to Use for Whom and When

Elise C. Kohn, Jung-min Lee, S. Percy Ivy
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (23): 7155–7157.
https://doi.org/10.1158/1078-0432.CCR-17-2186
Published: 30 November 2017
View article titled, The <em>HRD</em> Decision<em>—</em>Which PARP Inhibitor to Use for Whom and When
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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

Abstract NTOC-112: GENOMIC SCARS AND CLINICAL RESPONSE TO COMBINATION THERAPY OF PARP AND ANGIOGENESIS INHIBITORS IN OVARIAN CANCER

Zhigang C. Wang, Nicolai Juul Birkbak, William T. Barry, Thomas M. Roberts, Eric P. Winer, J Dirk Iglehart, Ursula A. Matulonis, S. Percy Ivy, Joyce F. Liu
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (11_Supplement): NTOC-112.
https://doi.org/10.1158/1557-3265.OVCASYMP16-NTOC-112
Published: 31 May 2017
View article titled, Abstract NTOC-112: GENOMIC SCARS AND CLINICAL RESPONSE TO COMBINATION THERAPY OF PARP AND ANGIOGENESIS INHIBITORS IN OVARIAN CANCER
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

The Effect of Hepatic Impairment on Outcomes in Phase I Clinical Trials in Cancer Subjects

Aaron S. Mansfield, Michelle A. Rudek, Diana Vulih, Gary L. Smith, Pamela Jo Harris, S. Percy Ivy
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (22): 5472–5479.
https://doi.org/10.1158/1078-0432.CCR-16-0449
Published: 14 November 2016
View article titled, The Effect of Hepatic Impairment on Outcomes in Phase I Clinical Trials in Cancer Subjects
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Includes: Supplementary data
Journal Articles

Measuring Toxicity in Phase I Clinical Trials—Letter

David M. Hyman, Anne Eaton, S. Percy Ivy, David R. Spriggs, Alexia Iasonos
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (7): 1828.
https://doi.org/10.1158/1078-0432.CCR-15-3043
Published: 31 March 2016
View article titled, Measuring Toxicity in Phase I Clinical Trials—Letter
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Journal Articles

Toxicity Attribution in Phase I Trials: Evaluating the Effect of Dose on the Frequency of Related and Unrelated Toxicities

Anne Eaton, Alexia Iasonos, Mrinal M. Gounder, Erika G. Pamer, Alexander Drilon, Diana Vulih, Gary L. Smith, S. Percy Ivy, David R. Spriggs, David M. Hyman
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (3): 553–559.
https://doi.org/10.1158/1078-0432.CCR-15-0339
Published: 31 January 2016
View article titled, Toxicity Attribution in Phase I Trials: Evaluating the Effect of Dose on the Frequency of Related and Unrelated Toxicities
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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

Historical Controls for Metastatic Pancreatic Cancer: Benchmarks for Planning and Analyzing Single-Arm Phase II Trials

Philip A. Philip, Kari Chansky, Michael LeBlanc, Lawrence Rubinstein, Lesley Seymour, S. Percy Ivy, Steven R. Alberts, Paul J. Catalano, John Crowley
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2014) 20 (16): 4176–4185.
https://doi.org/10.1158/1078-0432.CCR-13-2024
Published: 13 August 2014
View article titled, Historical Controls for Metastatic Pancreatic Cancer: Benchmarks for Planning and Analyzing Single-Arm Phase II Trials
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Journal Articles

Developing Standards for Breakthrough Therapy Designation in Oncology

Sandra J. Horning, Daniel A. Haber, Wendy K.D. Selig, S. Percy Ivy, Samantha A. Roberts, Jeff D. Allen, Ellen V. Sigal, Charles L. Sawyers
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (16): 4297–4304.
https://doi.org/10.1158/1078-0432.CCR-13-0523
Published: 13 August 2013
View article titled, Developing Standards for Breakthrough Therapy Designation in Oncology
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Includes: Supplementary data
Journal Articles

Phase I Study of Pazopanib in Patients with Advanced Solid Tumors and Hepatic Dysfunction: A National Cancer Institute Organ Dysfunction Working Group Study

Stephen I. Shibata, Vincent Chung, Timothy W. Synold, Jeffrey A. Longmate, A. Benjamin Suttle, Lone H. Ottesen, Heinz-Josef Lenz, Shivaani Kummar, R. Donald Harvey, Anne L. Hamilton, Bert H. O'Neil, John Sarantopoulos, Patricia LoRusso, Michelle A. Rudek, Afshin Dowlati, Daniel L. Mulkerin, Chandra P. Belani, Leena Gandhi, S. Cecilia Lau, S. Percy Ivy, Edward M. Newman
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (13): 3631–3639.
https://doi.org/10.1158/1078-0432.CCR-12-3214
Published: 30 June 2013
View article titled, Phase I Study of Pazopanib in Patients with Advanced Solid Tumors and Hepatic Dysfunction: A National Cancer Institute Organ Dysfunction Working Group Study
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Includes: Supplementary data
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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