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

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

Clin Cancer Res (2021) 27 (23): 6366–6375.

DOI: https://doi.org/10.1158/1078-0432.CCR-20-4185

Published: 01 December 2022

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Includes: Supplementary data

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

Clin Cancer Res (2021) 27 (20): 5472–5481.

DOI: https://doi.org/10.1158/1078-0432.CCR-21-1799

Published: 15 October 2021

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Includes: Supplementary data

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

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

Clin Cancer Res (2020) 26 (21): 5588–5597.

DOI: https://doi.org/10.1158/1078-0432.CCR-20-1067

Published: 02 November 2020

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Includes: Supplementary data

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

Navid Hafez, Hope S. Rugo, Margaret A. Tempero, Elizabeth Fox, Gregory H. Reaman, Herbert Kim Lyerly, Desiree Walker, Patricia M. LoRusso

Clin Cancer Res (2020) 26 (18): 4743–4747.

DOI: https://doi.org/10.1158/1078-0432.CCR-19-4035

Published: 15 September 2020

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

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

Clin Cancer Res (2020) 26 (12): 2819–2826.

DOI: https://doi.org/10.1158/1078-0432.CCR-19-1430

Published: 15 June 2020

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Includes: Supplementary data

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Challenges with Novel Clinical Trial Designs: Master Protocols

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

Clin Cancer Res (2019) 25 (7): 2049–2057.

DOI: https://doi.org/10.1158/1078-0432.CCR-18-3544

Published: 01 April 2019

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

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

Clin Cancer Res (2018) 24 (17): 4072–4080.

DOI: https://doi.org/10.1158/1078-0432.CCR-17-3716

Published: 04 September 2018

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Phase 0 Trial of AZD1775 in First-Recurrence Glioblastoma Patients

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

Clin Cancer Res (2018) 24 (16): 3820–3828.

DOI: https://doi.org/10.1158/1078-0432.CCR-17-3348

Published: 14 August 2018

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

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

Clin Cancer Res (2017) 23 (17): 5015–5023.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-2888

Published: 31 August 2017

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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

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

Clin Cancer Res (2017) 23 (15): 4190–4202.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-3193

Published: 01 August 2017

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

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

Clin Cancer Res (2017) 23 (10): 2423–2432.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-1782

Published: 14 May 2017

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Includes: Supplementary data

Journal Articles

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

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

Clin Cancer Res (2016) 22 (13): 3157–3163.

DOI: https://doi.org/10.1158/1078-0432.CCR-15-2548

Published: 30 June 2016

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Includes: Supplementary data

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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

Clin Cancer Res (2016) 22 (13): 3227–3237.

DOI: https://doi.org/10.1158/1078-0432.CCR-15-0652

Published: 30 June 2016

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Includes: Supplementary data

Journal Articles

Next-Generation Sequencing to Guide Clinical Trials

Lillian L. Siu, Barbara A. Conley, Scott Boerner, Patricia M. LoRusso

Clin Cancer Res (2015) 21 (20): 4536–4544.

DOI: https://doi.org/10.1158/1078-0432.CCR-14-3215

Published: 14 October 2015

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Journal Articles

Advancing Clinical Trials to Streamline Drug Development

Susan E. Bates, Donald A. Berry, Sanjeeve Balasubramaniam, Stuart Bailey, Patricia M. LoRusso, Eric H. Rubin

Clin Cancer Res (2015) 21 (20): 4527–4535.

DOI: https://doi.org/10.1158/1078-0432.CCR-15-0039

Published: 14 October 2015

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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

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

Clin Cancer Res (2015) 21 (1): 60–67.

DOI: https://doi.org/10.1158/1078-0432.CCR-14-0607

Published: 05 January 2015

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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

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

Clin Cancer Res (2014) 20 (19): 5032–5040.

DOI: https://doi.org/10.1158/1078-0432.CCR-14-0570

Published: 30 September 2014

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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

Clin Cancer Res (2014) 20 (16): 4210–4217.

DOI: https://doi.org/10.1158/1078-0432.CCR-14-0521

Published: 13 August 2014

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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

Clin Cancer Res (2014) 20 (9): 2445–2456.

DOI: https://doi.org/10.1158/1078-0432.CCR-13-2403

Published: 30 April 2014

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Includes: Supplementary data

Journal Articles

The Intersection of Immune-Directed and Molecularly Targeted Therapy in Advanced Melanoma: Where We Have Been, Are, and Will Be

Ryan J. Sullivan, Patricia M. LoRusso, Keith T. Flaherty

Clin Cancer Res (2013) 19 (19): 5283–5291.

DOI: https://doi.org/10.1158/1078-0432.CCR-13-2151

Published: 01 October 2013

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NARROW

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

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

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

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

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

Challenges with Novel Clinical Trial Designs: Master Protocols

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

Phase 0 Trial of AZD1775 in First-Recurrence Glioblastoma Patients

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

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

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

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

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

Next-Generation Sequencing to Guide Clinical Trials

Advancing Clinical Trials to Streamline Drug Development

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

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

Design of Phase I Combination Trials: Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee

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

The Intersection of Immune-Directed and Molecularly Targeted Therapy in Advanced Melanoma: Where We Have Been, Are, and Will Be

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