Publications by authors named "Dale Shuster"

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Long-term efficacy and safety of pexidartinib in patients with tenosynovial giant cell tumor: final results of the ENLIVEN study.
Andrew J Wagner, William D Tap, Sebastian Bauer, Jean-Yves Blay, Jayesh Desai, Dale E Shuster

Oncologist· July 2025

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Application of the model-informed drug development paradigm to datopotamab deruxtecan dose selection for late-stage development.
Yasong Lu, Shuang Liang, Ying Hong, Naoyuki Tajima, Kashyap Patel, Dale Shuster

CPT Pharmacometrics Syst Pharmacol· January 2024

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Dosing Recommendation Based on the Effects of Different Meal Types on Pexidartinib Pharmacokinetics in Healthy Subjects: Implementation of Model-informed Drug Development Strategy.
Hamim Zahir, Ophelia Yin, Ching Hsu, Andrew J Wagner, Jason Jiang, Dale E Shuster

Clin Pharmacol Drug Dev· May 2023

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Pexidartinib Provides Modest Pain Relief in Patients With Tenosynovial Giant Cell Tumor: Results From ENLIVEN.
John H Healey, William D Tap, Heather L Gelhorn, Xin Ye, Rebecca M Speck, Dale Shuster

Clin Orthop Relat Res· January 2023

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Evaluation of Absorption and Metabolism-Based DDI Potential of Pexidartinib in Healthy Subjects.
Hamim Zahir, Jonathan Greenberg, Dale Shuster, Ching Hsu, Kengo Watanabe

Clin Pharmacokinet· November 2022

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Exposure-response analysis of efficacy and safety for pexidartinib in patients with tenosynovial giant cell tumor.
Ophelia Yin, Hamim Zahir, Jonathan French, Daniel Polhamus, Xiaoning Wang, Dale Shuster

CPT Pharmacometrics Syst Pharmacol· November 2021

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Pexidartinib improves physical functioning and stiffness in patients with tenosynovial giant cell tumor: results from the ENLIVEN randomized clinical trial.
Michiel Van De Sande, William D Tap, Heather L Gelhorn, Xin Ye, Rebecca M Speck, Dale Shuster

Acta Orthop· August 2021

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Pexidartinib Long-Term Hepatic Safety Profile in Patients with Tenosynovial Giant Cell Tumors.
James H Lewis, Hans Gelderblom, Michiel van de Sande, Silvia Stacchiotti, John H Healey, Dale E Shuster

Oncologist· May 2021

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Population Pharmacokinetic Analysis of Pexidartinib in Healthy Subjects and Patients With Tenosynovial Giant Cell Tumor or Other Solid Tumors.
Ophelia Yin, Andrew J Wagner, Jia Kang, William Knebel, Hamim Zahir, Dale Shuster

J Clin Pharmacol· April 2021

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Long-term outcomes of pexidartinib in tenosynovial giant cell tumors.
Hans Gelderblom, Andrew J Wagner, William D Tap, Emanuela Palmerini, Zev A Wainberg, Dale E Shuster

Cancer· March 2021

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Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial.
William D Tap, Hans Gelderblom, Emanuela Palmerini, Jayesh Desai, Sebastian Bauer, Dale E Shuster

Lancet· August 2019

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Tivantinib in Combination with Erlotinib versus Erlotinib Alone for EGFR-Mutant NSCLC: An Exploratory Analysis of the Phase 3 MARQUEE Study.
Giorgio V Scagliotti, Dale Shuster, Sergey Orlov, Joachim von Pawel, Frances A Shepherd

J Thorac Oncol· June 2018

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Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study.
Lorenza Rimassa, Eric Assenat, Markus Peck-Radosavljevic, Marc Pracht, Vittorina Zagonel, Dale Shuster

Lancet Oncol· May 2018

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Prognostic value of the neutrophil-to-lymphocyte ratio in the ARQ 197-215 second-line study for advanced hepatocellular carcinoma.
Nicola Personeni, Laura Giordano, Giovanni Abbadessa, Camillo Porta, Ivan Borbath, Dale Shuster

Oncotarget· February 2017

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Tumor and circulating biomarkers in patients with second-line hepatocellular carcinoma from the randomized phase II study with tivantinib.
Lorenza Rimassa, Giovanni Abbadessa, Nicola Personeni, Camillo Porta, Ivan Borbath, Dale Shuster

Oncotarget· November 2016

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Phase III Multinational, Randomized, Double-Blind, Placebo-Controlled Study of Tivantinib (ARQ 197) Plus Erlotinib Versus Erlotinib Alone in Previously Treated Patients With Locally Advanced or Metastatic Nonsquamous Non-Small-Cell Lung Cancer.
Giorgio Scagliotti, Joachim von Pawel, Silvia Novello, Rodryg Ramlau, Adolfo Favaretto, Dale Shuster

J Clin Oncol· August 2015

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A phase II study of eribulin mesylate (E7389) in patients with advanced, previously treated non-small-cell lung cancer.
Alexander I Spira, Nicholas O Iannotti, Michael A Savin, Marcus Neubauer, Nashat Y Gabrail, Dale Shuster

Clin Lung Cancer· January 2012

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Phase II study of the halichondrin B analog eribulin mesylate in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline, a taxane, and capecitabine.
Javier Cortes, Linda Vahdat, Joanne L Blum, Chris Twelves, Mario Campone, Dale E Shuster

J Clin Oncol· September 2010

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The odyssey of marine pharmaceuticals: a current pipeline perspective.
Alejandro M S Mayer, Keith B Glaser, Carmen Cuevas, Robert S Jacobs, William Kem, Dale E Shuster

Trends Pharmacol Sci· June 2010

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Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane.
Linda T Vahdat, Brian Pruitt, Carol J Fabian, Ragene R Rivera, David A Smith, Dale E Shuster

J Clin Oncol· June 2009

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Phase I study of eribulin mesylate administered once every 21 days in patients with advanced solid tumors.
Antoinette R Tan, Eric H Rubin, Diana C Walton, Dale E Shuster, Y Nancy Wong

Clin Cancer Res· June 2009

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A phase I study of eribulin mesylate (E7389), a mechanistically novel inhibitor of microtubule dynamics, in patients with advanced solid malignancies.
Sanjay Goel, Alain C Mita, Monica Mita, Eric K Rowinsky, Quincy S Chu, Dale E Shuster

Clin Cancer Res· June 2009

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A canine model of cutaneous late-phase reactions: prednisolone inhibition of cellular and cytokine responses.
Cherie M Pucheu-Haston, Dale Shuster, Thierry Olivry, Philippe Brianceau, Patrick Lockwood

Immunology· February 2006

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A European survey of antimicrobial susceptibility among zoonotic and commensal bacteria isolated from food-producing animals.
Robin Bywater, Hubert Deluyker, Erik Deroover, Anno de Jong, Hervé Marion, Dale Shuster

J Antimicrob Chemother· October 2004

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