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Michelle A. Rudek
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Journal Articles

Response Rate and Molecular Correlates to Encorafenib and Binimetinib in BRAF-V600E Mutant High-Grade Glioma

Karisa C. Schreck, Roy E. Strowd, Louis B. Nabors, Benjamin M. Ellingson, Michael Chang, Sze K. Tan, Zied Abdullaev, Rust Turakulov, Kenneth Aldape, Neeraja Danda, Serena Desideri, Joy Fisher, Michaella Iacoboni, Trisha Surakus, Michelle A. Rudek, Chetan Bettegowda, Stuart A. Grossman, Xiaobu Ye
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (10): 2048–2056.
https://doi.org/10.1158/1078-0432.CCR-23-3241
Published: 15 May 2024
View articletitled, Response Rate and Molecular Correlates to Encorafenib and Binimetinib in BRAF-V600E Mutant High-Grade Glioma
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Includes: Supplementary data
Journal Articles

Phase I Trial of the Multi-kinase Inhibitor Cabozantinib, a CYP3A4 Substrate, plus CYP3A4-Interacting Antiretroviral Therapy in People Living with HIV and Cancer (AMC-087)

Missak Haigentz, Jr, Jeannette Y. Lee, Elizabeth Y. Chiao, David M. Aboulafia, Lee Ratner, Richard F. Ambinder, Robert A. Baiocchi, Ronald T. Mitsuyasu, William Wachsman, Joseph A. Sparano, Michelle A. Rudek
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (24): 5038–5046.
https://doi.org/10.1158/1078-0432.CCR-23-1142
Published: 15 December 2023
View articletitled, Phase I Trial of the Multi-kinase Inhibitor Cabozantinib, a CYP3A4 Substrate, plus CYP3A4-Interacting Antiretroviral Therapy in People Living with HIV and Cancer (AMC-087)
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Includes: Supplementary data
Journal Articles

Phase I Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844)

Evanthia T. Roussos Torres, Christine Rafie, Chenguang Wang, David Lim, Adam Brufsky, Patricia LoRusso, Joseph Paul Eder, Vincent Chung, Melinda Downs, Molly Geare, Richard Piekarz, Howard Streicher, Leslie Anforth, Michelle A. Rudek, Qingfeng Zhu, Sepideh Besharati, Ashley Cimino-Mathews, Robert A. Anders, Vered Stearns, Elizabeth M. Jaffee, Roisin M. Connolly
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (21): 5828–5837.
https://doi.org/10.1158/1078-0432.CCR-20-5017
Published: 01 November 2021
View articletitled, Phase I Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844)
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Includes: Supplementary data
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 articletitled, 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 Trial of the VEGF Receptor Tyrosine Kinase Inhibitor Pazopanib in Combination with the MEK Inhibitor Trametinib in Advanced Solid Tumors and Differentiated Thyroid Cancers

Razelle Kurzrock, Douglas W. Ball, Marianna L. Zahurak, Barry D. Nelkin, Vivek Subbiah, Shabina Ahmed, Ashley O'Connor, Enusha Karunsena, Rose M. Parkinson, Justin A. Bishop, Yoonji Ha, Rajni Sharma, Christopher D. Gocke, Ralph Zinner, Michelle A. Rudek, Steven I. Sherman, Nilofer S. Azad
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (18): 5475–5484.
https://doi.org/10.1158/1078-0432.CCR-18-1881
Published: 13 September 2019
View articletitled, A Phase I Trial of the VEGF Receptor Tyrosine Kinase Inhibitor Pazopanib in Combination with the MEK Inhibitor Trametinib in Advanced Solid Tumors and Differentiated Thyroid Cancers
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Includes: Supplementary data
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 articletitled, 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

Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies

Shailly Mehrotra, Mathangi Gopalakrishnan, Jogarao Gobburu, Jiuping Ji, Jacqueline M. Greer, Richard Piekarz, Judith E. Karp, Keith W. Pratz, Michelle A. Rudek
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (21): 6421–6429.
https://doi.org/10.1158/1078-0432.CCR-17-0143
Published: 31 October 2017
View articletitled, Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
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Includes: Supplementary data
Journal Articles

Exposure–Response Analysis of Alvocidib (Flavopiridol) Treatment by Bolus or Hybrid Administration in Newly Diagnosed or Relapsed/Refractory Acute Leukemia Patients

Carl LaCerte, Vijay Ivaturi, Joga Gobburu, Jacqueline M. Greer, L. Austin Doyle, John J. Wright, Judith E. Karp, Michelle A. Rudek
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (14): 3592–3600.
https://doi.org/10.1158/1078-0432.CCR-16-2629
Published: 13 July 2017
View articletitled, Exposure–Response Analysis of Alvocidib (Flavopiridol) Treatment by Bolus or Hybrid Administration in Newly Diagnosed or Relapsed/Refractory Acute Leukemia Patients
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Includes: Supplementary data
Journal Articles

Combination Epigenetic Therapy in Advanced Breast Cancer with 5-Azacitidine and Entinostat: A Phase II National Cancer Institute/Stand Up to Cancer Study

Roisin M. Connolly, Huili Li, Rachel C. Jankowitz, Zhe Zhang, Michelle A. Rudek, Stacie C. Jeter, Shannon A. Slater, Penny Powers, Antonio C. Wolff, John H. Fetting, Adam Brufsky, Richard Piekarz, Nita Ahuja, Peter W. Laird, Hui Shen, Daniel J. Weisenberger, Leslie Cope, James G. Herman, George Somlo, Agustin A. Garcia, Peter A. Jones, Stephen B. Baylin, Nancy E. Davidson, Cynthia A. Zahnow, Vered Stearns
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (11): 2691–2701.
https://doi.org/10.1158/1078-0432.CCR-16-1729
Published: 31 May 2017
View articletitled, Combination Epigenetic Therapy in Advanced Breast Cancer with 5-Azacitidine and Entinostat: A Phase II National Cancer Institute/Stand Up to Cancer Study
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Includes: Supplementary data
Journal Articles

A Phase I Study of Topotecan, Carboplatin and the PARP Inhibitor Veliparib in Acute Leukemias, Aggressive Myeloproliferative Neoplasms, and Chronic Myelomonocytic Leukemia

Keith W. Pratz, Michelle A. Rudek, Ivana Gojo, Mark R. Litzow, Michael A. McDevitt, Jiuping Ji, Larry M. Karnitz, James G. Herman, Robert J. Kinders, B. Douglas Smith, Steven D. Gore, Hetty E. Carraway, Margaret M. Showel, Douglas E. Gladstone, Mark J. Levis, Hua-Ling Tsai, Gary Rosner, Alice Chen, Scott H. Kaufmann, Judith E. Karp
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (4): 899–907.
https://doi.org/10.1158/1078-0432.CCR-16-1274
Published: 14 February 2017
View articletitled, A Phase I Study of Topotecan, Carboplatin and the PARP Inhibitor Veliparib in Acute Leukemias, Aggressive Myeloproliferative Neoplasms, and Chronic Myelomonocytic Leukemia
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Includes: Supplementary data
Journal Articles

A Phase 1 Study of the PARP Inhibitor Veliparib in Combination with Temozolomide in Acute Myeloid Leukemia

Ivana Gojo, Jan H. Beumer, Keith W. Pratz, Michael A. McDevitt, Maria R. Baer, Amanda L. Blackford, B. Douglas Smith, Steven D. Gore, Hetty E. Carraway, Margaret M. Showel, Mark J. Levis, Amy E. Dezern, Douglas E. Gladstone, Jiuping Jay Ji, Lihua Wang, Robert J. Kinders, Marie Pouquet, Ismail Ali-Walbi, Michelle A. Rudek, Weijie Poh, James G. Herman, Larry M. Karnitz, Scott H. Kaufmann, Alice Chen, Judith E. Karp
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (3): 697–706.
https://doi.org/10.1158/1078-0432.CCR-16-0984
Published: 31 January 2017
View articletitled, A Phase 1 Study of the PARP Inhibitor Veliparib in Combination with Temozolomide in Acute Myeloid Leukemia
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Includes: Supplementary data
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 articletitled, The Effect of Hepatic Impairment on Outcomes in Phase I Clinical Trials in Cancer Subjects
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Includes: Supplementary data
Journal Articles

Brain Penetration and Efficacy of Different Mebendazole Polymorphs in a Mouse Brain Tumor Model

Ren-Yuan Bai, Verena Staedtke, Teresia Wanjiku, Michelle A. Rudek, Avadhut Joshi, Gary L. Gallia, Gregory J. Riggins
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (15): 3462–3470.
https://doi.org/10.1158/1078-0432.CCR-14-2681
Published: 02 August 2015
View articletitled, Brain Penetration and Efficacy of Different Mebendazole Polymorphs in a Mouse Brain Tumor Model
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Includes: Supplementary data
Journal Articles

Biomarker Modulation following Short-Term Vorinostat in Women with Newly Diagnosed Primary Breast Cancer

Vered Stearns, Lisa K. Jacobs, MaryJo Fackler, Theodore N. Tsangaris, Michelle A. Rudek, Michaela Higgins, Julie Lange, Zandra Cheng, Shannon A. Slater, Stacie C. Jeter, Penny Powers, Susanne Briest, Calvin Chao, Carl Yoshizawa, Elizabeth Sugar, Igor Espinoza-Delgado, Saraswati Sukumar, Edward Gabrielson, Nancy E. Davidson
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (14): 4008–4016.
https://doi.org/10.1158/1078-0432.CCR-13-0033
Published: 15 July 2013
View articletitled, Biomarker Modulation following Short-Term Vorinostat in Women with Newly Diagnosed Primary Breast 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 articletitled, 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

Pharmacokinetics and Safety of Bortezomib in Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Phase I NCI Organ Dysfunction Working Group Study NCI-6432

Patricia M. LoRusso, Karthik Venkatakrishnan, Ramesh K. Ramanathan, John Sarantopoulos, Daniel Mulkerin, Stephen I. Shibata, Anne Hamilton, Afshin Dowlati, Sridhar Mani, Michelle A. Rudek, Chris H. Takimoto, Rachel Neuwirth, Dixie-Lee Esseltine, Percy Ivy
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (10): 2954–2963.
https://doi.org/10.1158/1078-0432.CCR-11-2873
Published: 14 May 2012
View articletitled, Pharmacokinetics and Safety of Bortezomib in Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Phase I NCI Organ Dysfunction Working Group Study NCI-6432
Open the PDF for Pharmacokinetics and Safety of Bortezomib in Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Phase I NCI Organ Dysfunction Working Group Study NCI-6432 in another window
Journal Articles

A Phase I Trial of Erlotinib and Concurrent Chemoradiotherapy for Stage III and IV (M0) Squamous Cell Carcinoma of the Head and Neck

Jill Gilbert, Michelle A. Rudek, Michaela J. Higgins, Ming Zhao, Sara Bienvenu, Nancy Tsottles, Richard Wahl, Arlene Forastiere, Maura Gillison
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (6): 1735–1742.
https://doi.org/10.1158/1078-0432.CCR-11-2544
Published: 14 March 2012
View articletitled, A Phase I Trial of Erlotinib and Concurrent Chemoradiotherapy for Stage III and IV (M0) Squamous Cell Carcinoma of the Head and Neck
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Journal Articles

Lysosomal Sequestration of Sunitinib: A Novel Mechanism of Drug Resistance

Kristy J. Gotink, Henk J. Broxterman, Mariette Labots, Richard R. de Haas, Henk Dekker, Richard J. Honeywell, Michelle A. Rudek, Laurens V. Beerepoot, René J. Musters, Gerrit Jansen, Arjan W. Griffioen, Yehuda G. Assaraf, Roberto Pili, Godefridus J. Peters, Henk M.W. Verheul
Journal: Clinical Cancer Research
Clin Cancer Res (2011) 17 (23): 7337–7346.
https://doi.org/10.1158/1078-0432.CCR-11-1667
Published: 30 November 2011
View articletitled, Lysosomal Sequestration of Sunitinib: A Novel Mechanism of Drug Resistance
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Includes: Supplementary data
Journal Articles

A Pharmacodynamic Study of Rapamycin in Men with Intermediate- to High-Risk Localized Prostate Cancer

Andrew J. Armstrong, George J. Netto, Michelle A. Rudek, Susan Halabi, David P. Wood, Patricia A. Creel, Kelly Mundy, S. Lindsay Davis, Ting Wang, Roula Albadine, Luciana Schultz, Alan W. Partin, Antonio Jimeno, Helen Fedor, Phillip G. Febbo, Daniel J. George, Robin Gurganus, Angelo M. De Marzo, Michael A. Carducci
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (11): 3057–3066.
https://doi.org/10.1158/1078-0432.CCR-10-0124
Published: 31 May 2010
View articletitled, A Pharmacodynamic Study of Rapamycin in Men with Intermediate- to High-Risk Localized Prostate Cancer
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Includes: Supplementary data
Journal Articles

TKTL1 Is Activated by Promoter Hypomethylation and Contributes to Head and Neck Squamous Cell Carcinoma Carcinogenesis through Increased Aerobic Glycolysis and HIF1α Stabilization

Wenyue Sun, Yan Liu, Chad A. Glazer, Chunbo Shao, Sheetal Bhan, Semra Demokan, Ming Zhao, Michelle A. Rudek, Patrick K. Ha, Joseph A. Califano
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (3): 857–866.
https://doi.org/10.1158/1078-0432.CCR-09-2604
Published: 01 February 2010
View articletitled, TKTL1 Is Activated by Promoter Hypomethylation and Contributes to Head and Neck Squamous Cell Carcinoma Carcinogenesis through Increased Aerobic Glycolysis and HIF1α Stabilization
Open the PDF for TKTL1 Is Activated by Promoter Hypomethylation and Contributes to Head and Neck Squamous Cell Carcinoma Carcinogenesis through Increased Aerobic Glycolysis and HIF1α Stabilization in another window
Includes: Supplementary data