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Amita Patnaik
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Journal Articles

Eganelisib, a First-in-Class PI3Kγ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial

David S. Hong, Michael Postow, Bartosz Chmielowski, Ryan Sullivan, Amita Patnaik, Ezra E.W. Cohen, Geoffrey Shapiro, Conor Steuer, Martin Gutierrez, Heather Yeckes-Rodin, Robert Ilaria, Jr, Brenda O'Connell, Joanna Peng, Guangbin Peng, Nora Zizlsperger, Anthony Tolcher, Jedd D. Wolchok
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (12): 2210–2219.
https://doi.org/10.1158/1078-0432.CCR-22-3313
Published: 13 June 2023
View article titled, Eganelisib, a First-in-Class PI3Kγ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial
Open the PDF for Eganelisib, a First-in-Class PI3Kγ Inhibitor, in Patients with Advanced Solid Tumors: Results of the Phase 1/1b MARIO-1 Trial in another window
Includes: Supplementary data
Journal Articles

Blocking TIM-3 in Treatment-refractory Advanced Solid Tumors: A Phase Ia/b Study of LY3321367 with or without an Anti-PD-L1 Antibody

James J. Harding, Victor Moreno, Yung-Jue Bang, Min Hee Hong, Amita Patnaik, José Trigo, Anna M. Szpurka, Noboru Yamamoto, Toshihiko Doi, Siqing Fu, Boris Calderon, Nieves Velez de Mendizabal, Emiliano Calvo, Danni Yu, Leena Gandhi, Zhuqing Tina Liu, Violeta Regnier Galvao, Ching Ching Leow, Maria J. de Miguel
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (8): 2168–2178.
https://doi.org/10.1158/1078-0432.CCR-20-4405
Published: 15 April 2021
View article titled, Blocking TIM-3 in Treatment-refractory Advanced Solid Tumors: A Phase Ia/b Study of LY3321367 with or without an Anti-PD-L1 Antibody
Open the PDF for Blocking TIM-3 in Treatment-refractory Advanced Solid Tumors: A Phase Ia/b Study of LY3321367 with or without an Anti-PD-L1 Antibody in another window
Includes: Supplementary data
Journal Articles

Safety and Clinical Activity of a New Anti-PD-L1 Antibody as Monotherapy or Combined with Targeted Therapy in Advanced Solid Tumors: The PACT Phase Ia/Ib Trial

Amita Patnaik, Timothy A. Yap, Hyun Cheol Chung, Maria J. de Miguel, Yung-Jue Bang, Chia-Chi Lin, Wu-Chou Su, Antoine Italiano, Kay Hoong Chow, Anna M. Szpurka, Danni Yu, Yumin Zhao, Michelle Carlsen, Shelly Schmidt, Burkhard Vangerow, Leena Gandhi, Xiaojian Xu, Johanna Bendell
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (5): 1267–1277.
https://doi.org/10.1158/1078-0432.CCR-20-2821
Published: 01 March 2021
View article titled, Safety and Clinical Activity of a New Anti-PD-L1 Antibody as Monotherapy or Combined with Targeted Therapy in Advanced Solid Tumors: The PACT Phase Ia/Ib Trial
Open the PDF for Safety and Clinical Activity of a New Anti-PD-L1 Antibody as Monotherapy or Combined with Targeted Therapy in Advanced Solid Tumors: The PACT Phase Ia/Ib Trial in another window
Includes: Supplementary data
Journal Articles

Correction: Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab

Richard W. Joseph, Jeroen Elassaiss-Schaap, Richard Kefford, Wen-Jen Hwu, Jedd D. Wolchok, Anthony M. Joshua, Antoni Ribas, F. Stephen Hodi, Omid Hamid, Caroline Robert, Adil Daud, Roxana Dronca, Peter Hersey, Jeffrey S. Weber, Amita Patnaik, Dinesh P. de Alwis, Andrea Perrone, Jin Zhang, S. Peter Kang, Scot Ebbinghaus, Keaven M. Anderson, Tara C. Gangadhar
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (23): 6098.
https://doi.org/10.1158/1078-0432.CCR-18-3340
Published: 03 December 2018
View article titled, Correction: Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab
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Journal Articles

Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab

Richard W. Joseph, Jeroen Elassaiss-Schaap, Richard Kefford, Wen-Jen Hwu, Jedd D. Wolchok, Anthony M. Joshua, Antoni Ribas, F. Stephen Hodi, Omid Hamid, Caroline Robert, Adil Daud, Roxana Dronca, Peter Hersey, Jeffrey S. Weber, Amita Patnaik, Dinesh P. de Alwis, Andrea Perrone, Jin Zhang, S. Peter Kang, Scot Ebbinghaus, Keaven M. Anderson, Tara C. Gangadhar
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2018) 24 (20): 4960–4967.
https://doi.org/10.1158/1078-0432.CCR-17-2386
Published: 15 October 2018
View article titled, Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab
Open the PDF for Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab in another window
Includes: Supplementary data
Journal Articles

Phase Ib Study of Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Combination with Pembrolizumab (MK-3475) in Patients with Advanced Solid Tumors

Anthony W. Tolcher, Mario Sznol, Siwen Hu-Lieskovan, Kyriakos P. Papadopoulos, Amita Patnaik, Drew W. Rasco, Donna Di Gravio, Bo Huang, Dhiraj Gambhire, Ying Chen, Aron D. Thall, Nuzhat Pathan, Emmett V. Schmidt, Laura Q.M. Chow
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2017) 23 (18): 5349–5357.
https://doi.org/10.1158/1078-0432.CCR-17-1243
Published: 14 September 2017
View article titled, Phase Ib Study of Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Combination with Pembrolizumab (MK-3475) in Patients with Advanced Solid Tumors
Open the PDF for Phase Ib Study of Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Combination with Pembrolizumab (MK-3475) in Patients with Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

A Phase I Dose-Escalation Study Evaluating the Safety Tolerability and Pharmacokinetics of CUDC-427, a Potent, Oral, Monovalent IAP Antagonist, in Patients with Refractory Solid Tumors

Anthony W. Tolcher, Johanna C. Bendell, Kyriakos P. Papadopoulos, Howard A. Burris, Amita Patnaik, Wayne J. Fairbrother, Harvey Wong, Nageshwar Budha, Walter C. Darbonne, Franklin Peale, Michael Mamounas, Stephanie Royer-Joo, Ron Yu, Chia C. Portera, Jeffrey R. Infante
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (18): 4567–4573.
https://doi.org/10.1158/1078-0432.CCR-16-0308
Published: 15 September 2016
View article titled, A Phase I Dose-Escalation Study Evaluating the Safety Tolerability and Pharmacokinetics of CUDC-427, a Potent, Oral, Monovalent IAP Antagonist, in Patients with Refractory Solid Tumors
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Journal Articles

A Phase I First-in-Human Study of Nesvacumab (REGN910), a Fully Human Anti–Angiopoietin-2 (Ang2) Monoclonal Antibody, in Patients with Advanced Solid Tumors

Kyriakos P. Papadopoulos, Robin Kate Kelley, Anthony W. Tolcher, Albiruni R. Abdul Razak, Katherine Van Loon, Amita Patnaik, Philippe L. Bedard, Ariceli A. Alfaro, Muralidhar Beeram, Lieve Adriaens, Carrie M. Brownstein, Israel Lowy, Ana Kostic, Pamela A. Trail, Bo Gao, A. Thomas DiCioccio, Lillian L. Siu
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (6): 1348–1355.
https://doi.org/10.1158/1078-0432.CCR-15-1221
Published: 14 March 2016
View article titled, A Phase I First-in-Human Study of Nesvacumab (REGN910), a Fully Human Anti–Angiopoietin-2 (Ang2) Monoclonal Antibody, in Patients with Advanced Solid Tumors
Open the PDF for A Phase I First-in-Human Study of Nesvacumab (REGN910), a Fully Human Anti–Angiopoietin-2 (Ang2) Monoclonal Antibody, in Patients with Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

A First-in-Human Phase I Study of the Oral p38 MAPK Inhibitor, Ralimetinib (LY2228820 Dimesylate), in Patients with Advanced Cancer

Amita Patnaik, Paul Haluska, Anthony W. Tolcher, Charles Erlichman, Kyriakos P. Papadopoulos, Janet L. Lensing, Muralidhar Beeram, Julian R. Molina, Drew W. Rasco, Rebecca R. Arcos, Claudia S. Kelly, Sameera R. Wijayawardana, Xuekui Zhang, Louis F. Stancato, Robert Bell, Peipei Shi, Palaniappan Kulanthaivel, Celine Pitou, Lynette B. Mulle, Daphne L. Farrington, Edward M. Chan, Matthew P. Goetz
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2016) 22 (5): 1095–1102.
https://doi.org/10.1158/1078-0432.CCR-15-1718
Published: 29 February 2016
View article titled, A First-in-Human Phase I Study of the Oral p38 MAPK Inhibitor, Ralimetinib (LY2228820 Dimesylate), in Patients with Advanced Cancer
Open the PDF for A First-in-Human Phase I Study of the Oral p38 MAPK Inhibitor, Ralimetinib (LY2228820 Dimesylate), in Patients with Advanced Cancer in another window
Includes: Supplementary data
Journal Articles

Safety, Pharmacokinetics, and Pharmacodynamics of a Humanized Anti-Semaphorin 4D Antibody, in a First-In-Human Study of Patients with Advanced Solid Tumors

Amita Patnaik, Glen J. Weiss, John E. Leonard, Drew Warren Rasco, Jasgit C. Sachdev, Terrence L. Fisher, Laurie A. Winter, Christine Reilly, Robert B. Parker, Danielle Mutz, Lisa Blaydorn, Anthony W. Tolcher, Maurice Zauderer, Ramesh K. Ramanathan
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2016) 22 (4): 827–836.
https://doi.org/10.1158/1078-0432.CCR-15-0431
Published: 14 February 2016
View article titled, Safety, Pharmacokinetics, and Pharmacodynamics of a Humanized Anti-Semaphorin 4D Antibody, in a First-In-Human Study of Patients with Advanced Solid Tumors
Open the PDF for Safety, Pharmacokinetics, and Pharmacodynamics of a Humanized Anti-Semaphorin 4D Antibody, in a First-In-Human Study of Patients with Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors

Amita Patnaik, S. Peter Kang, Drew Rasco, Kyriakos P. Papadopoulos, Jeroen Elassaiss-Schaap, Muralidhar Beeram, Ronald Drengler, Cong Chen, Lon Smith, Guillermo Espino, Kevin Gergich, Liliana Delgado, Adil Daud, Jill A. Lindia, Xiaoyun Nicole Li, Robert H. Pierce, Jennifer H. Yearley, Dianna Wu, Omar Laterza, Manfred Lehnert, Robert Iannone, Anthony W. Tolcher
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2015) 21 (19): 4286–4293.
https://doi.org/10.1158/1078-0432.CCR-14-2607
Published: 30 September 2015
View article titled, Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors
Open the PDF for Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

Antitumor Activity in RAS-Driven Tumors by Blocking AKT and MEK

Anthony W. Tolcher, Khurum Khan, Michael Ong, Udai Banerji, Vassiliki Papadimitrakopoulou, David R. Gandara, Amita Patnaik, Richard D. Baird, David Olmos, Christopher R. Garrett, Jeffrey M. Skolnik, Eric H. Rubin, Paul D. Smith, Pearl Huang, Maria Learoyd, Keith A. Shannon, Anne Morosky, Ernestina Tetteh, Ying-Ming Jou, Kyriakos P. Papadopoulos, Victor Moreno, Brianne Kaiser, Timothy A. Yap, Li Yan, Johann S. de Bono
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (4): 739–748.
https://doi.org/10.1158/1078-0432.CCR-14-1901
Published: 16 February 2015
View article titled, Antitumor Activity in <em>RAS</em>-Driven Tumors by Blocking AKT and MEK
Open the PDF for Antitumor Activity in <em>RAS</em>-Driven Tumors by Blocking AKT and MEK in another window
Includes: Supplementary data
Journal Articles

Interrogating Two Schedules of the AKT Inhibitor MK-2206 in Patients with Advanced Solid Tumors Incorporating Novel Pharmacodynamic and Functional Imaging Biomarkers

Timothy A. Yap, Li Yan, Amita Patnaik, Nina Tunariu, Andrea Biondo, Ivy Fearen, Kyriakos P. Papadopoulos, David Olmos, Richard Baird, Liliana Delgado, Ernestina Tetteh, Robert A. Beckman, Lisa Lupinacci, Ruth Riisnaes, Shaun Decordova, Simon P. Heaton, Karen Swales, Nandita M. deSouza, Martin O. Leach, Michelle D. Garrett, Daniel M. Sullivan, Johann S. de Bono, Anthony W. Tolcher
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (22): 5672–5685.
https://doi.org/10.1158/1078-0432.CCR-14-0868
Published: 13 November 2014
View article titled, Interrogating Two Schedules of the AKT Inhibitor MK-2206 in Patients with Advanced Solid Tumors Incorporating Novel Pharmacodynamic and Functional Imaging Biomarkers
Open the PDF for Interrogating Two Schedules of the AKT Inhibitor MK-2206 in Patients with Advanced Solid Tumors Incorporating Novel Pharmacodynamic and Functional Imaging Biomarkers in another window
Includes: Supplementary data
Journal Articles

Phase I First-in-Human Study of CUDC-101, a Multitargeted Inhibitor of HDACs, EGFR, and HER2 in Patients with Advanced Solid Tumors

Toshio Shimizu, Patricia M. LoRusso, Kyri P. Papadopoulos, Amita Patnaik, Muralidhar Beeram, Lon S. Smith, Drew W. Rasco, Theresa A. Mays, Glenda Chambers, Anna Ma, Jing Wang, Robert Laliberte, Maurizio Voi, Anthony W. Tolcher
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (19): 5032–5040.
https://doi.org/10.1158/1078-0432.CCR-14-0570
Published: 30 September 2014
View article titled, Phase I First-in-Human Study of CUDC-101, a Multitargeted Inhibitor of HDACs, EGFR, and HER2 in Patients with Advanced Solid Tumors
Open the PDF for Phase I First-in-Human Study of CUDC-101, a Multitargeted Inhibitor of HDACs, EGFR, and HER2 in Patients with Advanced Solid Tumors in another window
Journal Articles

Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of SAR245409 (XL765), a Novel, Orally Administered PI3K/mTOR Inhibitor in Patients with Advanced Solid Tumors

Kyriakos P. Papadopoulos, Josep Tabernero, Ben Markman, Amita Patnaik, Anthony W. Tolcher, José Baselga, Weiliang Shi, Coumaran Egile, Rodrigo Ruiz-Soto, A. Douglas Laird, Dale Miles, Patricia M. LoRusso
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2014) 20 (9): 2445–2456.
https://doi.org/10.1158/1078-0432.CCR-13-2403
Published: 30 April 2014
View article titled, Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of SAR245409 (XL765), a Novel, Orally Administered PI3K/mTOR Inhibitor in Patients with Advanced Solid Tumors
Open the PDF for Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of SAR245409 (XL765), a Novel, Orally Administered PI3K/mTOR Inhibitor in Patients with Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

Pharmacokinetic and Pharmacodynamic Analysis of Circulating Biomarkers of Anti-NRP1, a Novel Antiangiogenesis Agent, in Two Phase I Trials in Patients with Advanced Solid Tumors

Yan Xin, Jessica Li, Jenny Wu, Rashell Kinard, Colin D. Weekes, Amita Patnaik, Patricia LoRusso, Rainer Brachmann, Raymond K. Tong, Yibing Yan, Ryan Watts, Shuang Bai, Priti S. Hegde
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (21): 6040–6048.
https://doi.org/10.1158/1078-0432.CCR-12-1652
Published: 06 November 2012
View article titled, Pharmacokinetic and Pharmacodynamic Analysis of Circulating Biomarkers of Anti-NRP1, a Novel Antiangiogenesis Agent, in Two Phase I Trials in Patients with Advanced Solid Tumors
Open the PDF for Pharmacokinetic and Pharmacodynamic Analysis of Circulating Biomarkers of Anti-NRP1, a Novel Antiangiogenesis Agent, in Two Phase I Trials in Patients with Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

The Clinical Effect of the Dual-Targeting Strategy Involving PI3K/AKT/mTOR and RAS/MEK/ERK Pathways in Patients with Advanced Cancer

Toshio Shimizu, Anthony W. Tolcher, Kyriakos P. Papadopoulos, Muralidhar Beeram, Drew W. Rasco, Lon S. Smith, Shelly Gunn, Leslie Smetzer, Theresa A. Mays, Brianne Kaiser, Michael J. Wick, Cathy Alvarez, Aracely Cavazos, Gina L. Mangold, Amita Patnaik
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (8): 2316–2325.
https://doi.org/10.1158/1078-0432.CCR-11-2381
Published: 16 April 2012
View article titled, The Clinical Effect of the Dual-Targeting Strategy Involving PI3K/AKT/mTOR and RAS/MEK/ERK Pathways in Patients with Advanced Cancer
Open the PDF for The Clinical Effect of the Dual-Targeting Strategy Involving PI3K/AKT/mTOR and RAS/MEK/ERK Pathways in Patients with Advanced Cancer in another window
Includes: Supplementary data
Journal Articles

Phase I and Pharmacokinetic Study of CT-322 (BMS-844203), a Targeted Adnectin Inhibitor of VEGFR-2 Based on a Domain of Human Fibronectin

Anthony W. Tolcher, Christopher J. Sweeney, Kyri Papadopoulos, Amita Patnaik, Elena G. Chiorean, Alain C. Mita, Kamalesh Sankhala, Eric Furfine, Jochem Gokemeijer, Lisa Iacono, Cheryl Eaton, Bruce A. Silver, Monica Mita
Journal: Clinical Cancer Research
Clin Cancer Res (2011) 17 (2): 363–371.
https://doi.org/10.1158/1078-0432.CCR-10-1411
Published: 16 January 2011
View article titled, Phase I and Pharmacokinetic Study of CT-322 (BMS-844203), a Targeted Adnectin Inhibitor of VEGFR-2 Based on a Domain of Human Fibronectin
Open the PDF for Phase I and Pharmacokinetic Study of CT-322 (BMS-844203), a Targeted Adnectin Inhibitor of VEGFR-2 Based on a Domain of Human Fibronectin in another window
Includes: Supplementary data
Journal Articles

A Phase I Study of Weekly R1507, A Human Monoclonal Antibody Insulin-like Growth Factor-I Receptor Antagonist, in Patients with Advanced Solid Tumors

Razelle Kurzrock, Amita Patnaik, Joseph Aisner, Terri Warren, Stephen Leong, Robert Benjamin, S. Gail Eckhardt, Joseph E. Eid, Gerard Greig, Kai Habben, Cinara D. McCarthy, Lia Gore
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (8): 2458–2465.
https://doi.org/10.1158/1078-0432.CCR-09-3220
Published: 14 April 2010
View article titled, A Phase I Study of Weekly R1507, A Human Monoclonal Antibody Insulin-like Growth Factor-I Receptor Antagonist, in Patients with Advanced Solid Tumors
Open the PDF for A Phase I Study of Weekly R1507, A Human Monoclonal Antibody Insulin-like Growth Factor-I Receptor Antagonist, in Patients with Advanced Solid Tumors in another window
Journal Articles

Phase I and Pharmacokinetic Study of XRP6258 (RPR 116258A), a Novel Taxane, Administered as a 1-Hour Infusion Every 3 Weeks in Patients with Advanced Solid Tumors

Alain C. Mita, Louis J. Denis, Eric K. Rowinsky, Johann S. DeBono, Andrew D. Goetz, Leonel Ochoa, Bahram Forouzesh, Muralidhar Beeram, Amita Patnaik, Kathleen Molpus, Dorothée Semiond, Michèle Besenval, Anthony W. Tolcher
Journal: Clinical Cancer Research
Clin Cancer Res (2009) 15 (2): 723–730.
https://doi.org/10.1158/1078-0432.CCR-08-0596
Published: 15 January 2009
View article titled, Phase I and Pharmacokinetic Study of XRP6258 (RPR 116258A), a Novel Taxane, Administered as a 1-Hour Infusion Every 3 Weeks in Patients with Advanced Solid Tumors
Open the PDF for Phase I and Pharmacokinetic Study of XRP6258 (RPR 116258A), a Novel Taxane, Administered as a 1-Hour Infusion Every 3 Weeks in Patients with Advanced Solid Tumors in another window