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Patricia M. LoRusso
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Journal Articles

A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance

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Timothy A. Yap, Patricia M. LoRusso, Deborah J. Wong, Siwen Hu-Lieskovan, Kyriakos P. Papadopoulos, Josefin-Beate Holz, Urszula Grabowska, Cristian Gradinaru, Kin-Mei Leung, Sylwia Marshall, Claire S. Reader, Roslin Russell, Richard C.A. Sainson, Claire J. Seal, Christopher J. Shepherd, Fiona Germaschewski, Daniel Gliddon, Omer Stern, Lesley Young, Neil Brewis, Louis Kayitalire, Michelle Morrow
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (5): 888–898.
https://doi.org/10.1158/1078-0432.CCR-22-1449
Published: 01 March 2023
View articletitled, A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance
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Includes: Supplementary data
Journal Articles

Correction: A Phase I Study of an MPS1 Inhibitor (BAY 1217389) in Combination with Paclitaxel Using a Novel Randomized Continual Reassessment Method for Dose Escalation

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Florence Atrafi, Oliver Boix, Vivek Subbiah, Jennifer R. Diamond, Sant P. Chawla, Anthony W. Tolcher, Patricia M. LoRusso, Joseph P. Eder, Martin Gutierrez, Kumar Sankhala, Prabhu Rajagopalan, Isabelle Genvresse, Simon Langer, Ron H.J. Mathijssen, Jaap Verweij, Ingmar Bruns, Martijn P. Lolkema
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (13): 2969.
https://doi.org/10.1158/1078-0432.CCR-22-1792
Published: 01 July 2022
View articletitled, Correction: A Phase I Study of an MPS1 Inhibitor (BAY 1217389) in Combination with Paclitaxel Using a Novel Randomized Continual Reassessment Method for Dose Escalation
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Journal Articles

A Phase I Study of an MPS1 Inhibitor (BAY 1217389) in Combination with Paclitaxel Using a Novel Randomized Continual Reassessment Method for Dose Escalation

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Florence Atrafi, Oliver Boix, Vivek Subbiah, Jennifer R. Diamond, Sant P. Chawla, Anthony W. Tolcher, Patricia M. LoRusso, Joseph P. Eder, Martin Gutierrez, Kumar Sankhala, Prabhu Rajagopalan, Isabelle Genvresse, Simon Langer, Ron H.J. Mathijssen, Jaap Verweij, Ingmar Bruns, Martijn P. Lolkema
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (23): 6366–6375.
https://doi.org/10.1158/1078-0432.CCR-20-4185
Published: 01 December 2021
View articletitled, A Phase I Study of an MPS1 Inhibitor (BAY 1217389) in Combination with Paclitaxel Using a Novel Randomized Continual Reassessment Method for Dose Escalation
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Includes: Supplementary data
Journal Articles

A Grant-Based Experiment to Train Clinical Investigators: The AACR/ASCO Methods in Clinical Cancer Research Workshop

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Daniel D. Von Hoff, Gary M. Clark, Charles A. Coltman, Mary L. Disis, S.G. Eckhardt, Lee M. Ellis, Margaret Foti, Elizabeth Garrett-Mayer, Mithat Gönen, Manuel Hidalgo, Susan G. Hilsenbeck, John H. Littlefield, Patricia M. LoRusso, H. Kim Lyerly, Neal J. Meropol, Jyoti D. Patel, Steven Piantadosi, Dean A. Post, Meredith M. Regan, Yu Shyr, Margaret A. Tempero, Joel E. Tepper, Jamie Von Roenn, Louis M. Weiner, Donn C. Young, Nu V. Vu
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (20): 5472–5481.
https://doi.org/10.1158/1078-0432.CCR-21-1799
Published: 15 October 2021
View articletitled, A Grant-Based Experiment to Train Clinical Investigators: The AACR/ASCO Methods in Clinical Cancer Research Workshop
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Includes: Supplementary data
Journal Articles

A Phase I Study of DLYE5953A, an Anti-LY6E Antibody Covalently Linked to Monomethyl Auristatin E, in Patients with Refractory Solid Tumors

Free
Sara M. Tolaney, Khanh T. Do, Joseph P. Eder, Patricia M. LoRusso, Colin D. Weekes, Sarat Chandarlapaty, Ching-Wei Chang, Shang-Chiung Chen, Denise Nazzal, Eva Schuth, Flavia Brunstein, Montserrat Carrasco-Triguero, Walter C. Darbonne, Jennifer M. Giltnane, William M. Flanagan, S. Renee Commerford, Alexander Ungewickell, Geoffrey I. Shapiro, Shanu Modi
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2020) 26 (21): 5588–5597.
https://doi.org/10.1158/1078-0432.CCR-20-1067
Published: 02 November 2020
View articletitled, A Phase I Study of DLYE5953A, an Anti-LY6E Antibody Covalently Linked to Monomethyl Auristatin E, in Patients with Refractory Solid Tumors
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Includes: Supplementary data
Journal Articles

Novel Therapeutic Interventions Early in the Disease Trajectory: Drug Development Beyond the Refractory Setting

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Navid Hafez, Hope S. Rugo, Margaret A. Tempero, Elizabeth Fox, Gregory H. Reaman, Herbert Kim Lyerly, Desiree Walker, Patricia M. LoRusso
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (18): 4743–4747.
https://doi.org/10.1158/1078-0432.CCR-19-4035
Published: 15 September 2020
View articletitled, Novel Therapeutic Interventions Early in the Disease Trajectory: Drug Development Beyond the Refractory Setting
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Journal Articles

A Phase I Study of ASTX660, an Antagonist of Inhibitors of Apoptosis Proteins, in Adults with Advanced Cancers or Lymphoma

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Monica M. Mita, Patricia M. LoRusso, Kyriakos P. Papadopoulos, Michael S. Gordon, Alain C. Mita, Roberta Ferraldeschi, Harold Keer, Aram Oganesian, Xiang Yao Su, Simone Jueliger, Anthony W. Tolcher
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2020) 26 (12): 2819–2826.
https://doi.org/10.1158/1078-0432.CCR-19-1430
Published: 15 June 2020
View articletitled, A Phase I Study of ASTX660, an Antagonist of Inhibitors of Apoptosis Proteins, in Adults with Advanced Cancers or Lymphoma
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Includes: Supplementary data
Journal Articles

Challenges with Novel Clinical Trial Designs: Master Protocols

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Michael Cecchini, Eric H. Rubin, Gideon M. Blumenthal, Kassa Ayalew, Howard A. Burris, Michele Russell-Einhorn, Hildy Dillon, H. Kim Lyerly, Gregory H. Reaman, Scott Boerner, Patricia M. LoRusso
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (7): 2049–2057.
https://doi.org/10.1158/1078-0432.CCR-18-3544
Published: 01 April 2019
View articletitled, Challenges with Novel Clinical Trial Designs: Master Protocols
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Journal Articles

Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors

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Daniel D. Von Hoff, Drew W. Rasco, Elisabeth I. Heath, Pamela N. Munster, Jan H.M. Schellens, Nicolas Isambert, Christophe Le Tourneau, Bert O'Neil, Ron H.J. Mathijssen, Jose A. Lopez-Martin, W. Jeff Edenfield, Miguel Martin, Patricia M. LoRusso, Gordon L. Bray, Jorge DiMartino, Aaron Nguyen, Kejian Liu, Eric Laille, Johanna C. Bendell
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (17): 4072–4080.
https://doi.org/10.1158/1078-0432.CCR-17-3716
Published: 04 September 2018
View articletitled, Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors
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Includes: Supplementary data
Journal Articles

Phase 0 Trial of AZD1775 in First-Recurrence Glioblastoma Patients

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Nader Sanai, Jing Li, Julie Boerner, Karri Stark, Jianmei Wu, Seongho Kim, Alanna Derogatis, Shwetal Mehta, Harshil D. Dhruv, Lance K. Heilbrun, Michael E. Berens, Patricia M. LoRusso
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2018) 24 (16): 3820–3828.
https://doi.org/10.1158/1078-0432.CCR-17-3348
Published: 14 August 2018
View articletitled, Phase 0 Trial of AZD1775 in First-Recurrence Glioblastoma Patients
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Includes: Supplementary data
Journal Articles

A First-in-Human, Phase I, Dose-Escalation Study of TAK-117, a Selective PI3Kα Isoform Inhibitor, in Patients with Advanced Solid Malignancies

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Dejan Juric, Johann S. de Bono, Patricia M. LoRusso, John Nemunaitis, Elisabeth I. Heath, Eunice L. Kwak, Teresa Macarulla Mercadé, Elena Geuna, Maria Jose de Miguel-Luken, Chirag Patel, Keisuke Kuida, Serap Sankoh, Eric H. Westin, Fabian Zohren, Yaping Shou, Josep Tabernero
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2017) 23 (17): 5015–5023.
https://doi.org/10.1158/1078-0432.CCR-16-2888
Published: 31 August 2017
View articletitled, A First-in-Human, Phase I, Dose-Escalation Study of TAK-117, a Selective PI3Kα Isoform Inhibitor, in Patients with Advanced Solid Malignancies
Open the PDF for A First-in-Human, Phase I, Dose-Escalation Study of TAK-117, a Selective PI3Kα Isoform Inhibitor, in Patients with Advanced Solid Malignancies in another window
Includes: Supplementary data
Journal Articles

64Cu-MM-302 Positron Emission Tomography Quantifies Variability of Enhanced Permeability and Retention of Nanoparticles in Relation to Treatment Response in Patients with Metastatic Breast Cancer

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Helen Lee, Anthony F. Shields, Barry A. Siegel, Kathy D. Miller, Ian Krop, Cynthia X. Ma, Patricia M. LoRusso, Pamela N. Munster, Karen Campbell, Daniel F. Gaddy, Shannon C. Leonard, Elena Geretti, Stephanie J. Blocker, Dmitri B. Kirpotin, Victor Moyo, Thomas J. Wickham, Bart S. Hendriks
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (15): 4190–4202.
https://doi.org/10.1158/1078-0432.CCR-16-3193
Published: 01 August 2017
View articletitled, 64Cu-MM-302 Positron Emission Tomography Quantifies Variability of Enhanced Permeability and Retention of Nanoparticles in Relation to Treatment Response in Patients with Metastatic Breast Cancer
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Includes: Supplementary data
Journal Articles

Phase I Study of GDC-0425, a Checkpoint Kinase 1 Inhibitor, in Combination with Gemcitabine in Patients with Refractory Solid Tumors

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Jeffrey R. Infante, Antoine Hollebecque, Sophie Postel-Vinay, Todd M. Bauer, Elizabeth M. Blackwood, Marie Evangelista, Sami Mahrus, Franklin V. Peale, Xuyang Lu, Srikumar Sahasranaman, Rui Zhu, Yuan Chen, Xiao Ding, Elaine R. Murray, Jennifer L. Schutzman, Jennifer O. Lauchle, Jean-Charles Soria, Patricia M. LoRusso
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (10): 2423–2432.
https://doi.org/10.1158/1078-0432.CCR-16-1782
Published: 14 May 2017
View articletitled, Phase I Study of GDC-0425, a Checkpoint Kinase 1 Inhibitor, in Combination with Gemcitabine in Patients with Refractory Solid Tumors
Open the PDF for Phase I Study of GDC-0425, a Checkpoint Kinase 1 Inhibitor, in Combination with Gemcitabine in Patients with Refractory Solid Tumors in another window
Includes: Supplementary data
Journal Articles

Phase I Study of PSMA-Targeted Docetaxel-Containing Nanoparticle BIND-014 in Patients with Advanced Solid Tumors

Free
Daniel D. Von Hoff, Monica M. Mita, Ramesh K. Ramanathan, Glen J. Weiss, Alain C. Mita, Patricia M. LoRusso, Howard A. Burris, III, Lowell L. Hart, Susan C. Low, Donald M. Parsons, Stephen E. Zale, Jason M. Summa, Hagop Youssoufian, Jasgit C. Sachdev
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2016) 22 (13): 3157–3163.
https://doi.org/10.1158/1078-0432.CCR-15-2548
Published: 30 June 2016
View articletitled, Phase I Study of PSMA-Targeted Docetaxel-Containing Nanoparticle BIND-014 in Patients with Advanced Solid Tumors
Open the PDF for Phase I Study of PSMA-Targeted Docetaxel-Containing Nanoparticle BIND-014 in Patients with Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of the Poly(ADP-ribose) Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Combination with Irinotecan in Patients with Advanced Solid Tumors

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Patricia M. LoRusso, Jing Li, Angelika Burger, Lance K. Heilbrun, Edward A. Sausville, Scott A. Boerner, Daryn Smith, Mary Jo Pilat, Jie Zhang, Sara M. Tolaney, James M. Cleary, Alice P. Chen, Lawrence Rubinstein, Julie L. Boerner, Adam Bowditch, Dongpo Cai, Tracy Bell, Andrew Wolanski, Allison M. Marrero, Yiping Zhang, Jiuping Ji, Katherine Ferry-Galow, Robert J. Kinders, Ralph E. Parchment, Geoffrey I. Shapiro
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (13): 3227–3237.
https://doi.org/10.1158/1078-0432.CCR-15-0652
Published: 30 June 2016
View articletitled, Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of the Poly(ADP-ribose) Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Combination with Irinotecan in Patients with Advanced Solid Tumors
Open the PDF for Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of the Poly(ADP-ribose) Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Combination with Irinotecan in Patients with Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

Advancing Clinical Trials to Streamline Drug Development

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Susan E. Bates, Donald A. Berry, Sanjeeve Balasubramaniam, Stuart Bailey, Patricia M. LoRusso, Eric H. Rubin
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (20): 4527–4535.
https://doi.org/10.1158/1078-0432.CCR-15-0039
Published: 14 October 2015
View articletitled, Advancing Clinical Trials to Streamline Drug Development
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Journal Articles

Next-Generation Sequencing to Guide Clinical Trials

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Lillian L. Siu, Barbara A. Conley, Scott Boerner, Patricia M. LoRusso
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (20): 4536–4544.
https://doi.org/10.1158/1078-0432.CCR-14-3215
Published: 14 October 2015
View articletitled, Next-Generation Sequencing to Guide Clinical Trials
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Journal Articles

A Phase I, Dose-Finding Study in Patients with Advanced Solid Malignancies of the Oral γ-Secretase Inhibitor PF-03084014

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Wells A. Messersmith, Geoffrey I. Shapiro, James M. Cleary, Antonio Jimeno, Arvind Dasari, Bo Huang, M. Naveed Shaik, Rossano Cesari, Xianxian Zheng, Jennifer M. Reynolds, Patricia A. English, Karen R. McLachlan, Kenneth A. Kern, Patricia M. LoRusso
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2015) 21 (1): 60–67.
https://doi.org/10.1158/1078-0432.CCR-14-0607
Published: 05 January 2015
View articletitled, A Phase I, Dose-Finding Study in Patients with Advanced Solid Malignancies of the Oral γ-Secretase Inhibitor PF-03084014
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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

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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 articletitled, 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

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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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 articletitled, Design of Phase I Combination Trials: Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee
Open the PDF for Design of Phase I Combination Trials: Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee in another window