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R. Donald Harvey
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Journal Articles

Phase I Study of Elraglusib (9-ING-41), a Glycogen Synthase Kinase-3β Inhibitor, as Monotherapy or Combined with Chemotherapy in Patients with Advanced Malignancies

Benedito A. Carneiro, Ludimila Cavalcante, Devalingam Mahalingam, Anwaar Saeed, Howard Safran, Wen Wee Ma, Andrew L. Coveler, Steven Powell, Bruno Bastos, Elizabeth Davis, Vaibhav Sahai, William Mikrut, James Longstreth, Sheri Smith, Taylor Weisskittel, Hu Li, Brittany A. Borden, R. Donald Harvey, Solmaz Sahebjam, Andrés Cervantes, Austin Koukol, Andrew P. Mazar, Neeltje Steeghs, Razelle Kurzrock, Francis J. Giles, Pamela Munster
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (3): 522–531.
https://doi.org/10.1158/1078-0432.CCR-23-1916
Published: 01 February 2024
View article titled, Phase I Study of Elraglusib (9-ING-41), a Glycogen Synthase Kinase-3β Inhibitor, as Monotherapy or Combined with Chemotherapy in Patients with Advanced Malignancies
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Includes: Supplementary data
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

Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-Friends Recommendations

R. Donald Harvey, Suanna S. Bruinooge, Li Chen, Elizabeth Garrett-Mayer, Whitney Rhodes, Edward Stepanski, Thomas S. Uldrick, Gwynn Ison, Sean Khozin, Wendy S. Rubinstein, Caroline Schenkel, Robert S. Miller, George A. Komatsoulis, Richard L. Schilsky, Edward S. Kim
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (9): 2430–2434.
https://doi.org/10.1158/1078-0432.CCR-20-3857
Published: 01 May 2021
View article titled, Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-<em>Friends</em> Recommendations
Open the PDF for Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-<em>Friends</em> Recommendations in another window
Includes: Supplementary data
Journal Articles

FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs

Paul G. Kluetz, Patricia Keegan, George D. Demetri, Katherine Thornton, Joohee Sul, Janice Kim, Harvey Katzen, Laurie Beth Burke, R. Donald Harvey, Elleni Alebachew, Sundeep Agrawal, Abhilasha Nair, Martha Donoghue, William F. Pierce, Stacy S. Shord, Jennifer J. Gao, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (4): 916–921.
https://doi.org/10.1158/1078-0432.CCR-20-3213
Published: 15 February 2021
View article titled, FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs
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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

A Phase I Study of Safety, Pharmacokinetics, and Pharmacodynamics of Concurrent Everolimus and Buparlisib Treatment in Advanced Solid Tumors

Taofeek K. Owonikoko, R. Donald Harvey, Bradley Carthon, Zhengjia Chen, Colleen Lewis, Hanna Collins, Chao Zhang, David H. Lawson, Olatunji B. Alese, Mehmet Asim Bilen, Gabriel L. Sica, Conor E. Steuer, Walid L. Shaib, Christina Wu, Wayne B. Harris, Mehmet Akce, Ragini R. Kudchagkar, Bassel F. El-Rayes, Sagar Lonial, Suresh S. Ramalingam, Fadlo Raja Khuri
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (11): 2497–2505.
https://doi.org/10.1158/1078-0432.CCR-19-2697
Published: 01 June 2020
View article titled, A Phase I Study of Safety, Pharmacokinetics, and Pharmacodynamics of Concurrent Everolimus and Buparlisib Treatment in Advanced Solid Tumors
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Includes: Supplementary data
Journal Articles

Phase I Study of the Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (TAK-924/MLN4924) in Patients with Advanced Solid Tumors

John Sarantopoulos, Geoffrey I. Shapiro, Roger B. Cohen, Jeffrey W. Clark, John S. Kauh, Glen J. Weiss, James M. Cleary, Devalingam Mahalingam, Michael D. Pickard, Hélène M. Faessel, Allison J. Berger, Kristine Burke, George Mulligan, Bruce J. Dezube, R. Donald Harvey
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (4): 847–857.
https://doi.org/10.1158/1078-0432.CCR-15-1338
Published: 14 February 2016
View article titled, Phase I Study of the Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (TAK-924/MLN4924) in Patients with Advanced Solid Tumors
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Includes: Supplementary data
Journal Articles

Phase I Study of the Novel Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (MLN4924) in Patients with Relapsed/Refractory Multiple Myeloma or Lymphoma

Jatin J. Shah, Andrzej J. Jakubowiak, Owen A. O'Connor, Robert Z. Orlowski, R. Donald Harvey, Mitchell R. Smith, Daniel Lebovic, Catherine Diefenbach, Kevin Kelly, Zhaowei Hua, Allison J. Berger, George Mulligan, Hélène M. Faessel, Stephen Tirrell, Bruce J. Dezube, Sagar Lonial
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (1): 34–43.
https://doi.org/10.1158/1078-0432.CCR-15-1237
Published: 03 January 2016
View article titled, Phase I Study of the Novel Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (MLN4924) in Patients with Relapsed/Refractory Multiple Myeloma or Lymphoma
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Includes: Supplementary data
Journal Articles

A Translational, Pharmacodynamic, and Pharmacokinetic Phase IB Clinical Study of Everolimus in Resectable Non–Small Cell Lung Cancer

Taofeek K. Owonikoko, Suresh S. Ramalingam, Daniel L. Miller, Seth D. Force, Gabriel L. Sica, Jennifer Mendel, Zhengjia Chen, Andre Rogatko, Mourad Tighiouart, R. Donald Harvey, Sungjin Kim, Nabil F. Saba, Allan Pickens, Madhusmita Behera, Robert W. Fu, Michael R. Rossi, William F. Auffermann, William E. Torres, Rabih Bechara, Xingming Deng, Shi-Yong Sun, Haian Fu, Anthony A. Gal, Fadlo R. Khuri
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (8): 1859–1868.
https://doi.org/10.1158/1078-0432.CCR-14-1998
Published: 14 April 2015
View article titled, A Translational, Pharmacodynamic, and Pharmacokinetic Phase IB Clinical Study of Everolimus in Resectable Non–Small Cell Lung Cancer
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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

A Phase I/II Trial Combining High-Dose Melphalan and Autologous Transplant with Bortezomib for Multiple Myeloma: A Dose- and Schedule-Finding Study

Sagar Lonial, Jonathan Kaufman, Mourad Tighiouart, Ajay Nooka, Amelia A. Langston, Leonard T. Heffner, Claire Torre, Stephanie McMillan, Heather Renfroe, R. Donald Harvey, Mary J. Lechowicz, H. Jean Khoury, Christopher R. Flowers, Edmund K. Waller
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (20): 5079–5086.
https://doi.org/10.1158/1078-0432.CCR-10-1662
Published: 15 October 2010
View article titled, A Phase I/II Trial Combining High-Dose Melphalan and Autologous Transplant with Bortezomib for Multiple Myeloma: A Dose- and Schedule-Finding Study
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