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Phase 1b/2a study of galunisertib, a small molecule inhibitor of transforming growth factor-beta receptor I, in combination with standard temozolomide-based radiochemotherapy in patients with newly diagnosed malignant glioma

Investigational new drugs, 2020-10, Vol.38 (5), p.1570-1579

2020

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Novel transforming growth factor beta receptor I kinase inhibitor galunisertib (LY2157299) in advanced hepatocellular carcinoma

Liver international, 2019-08, Vol.39 (8), p.1468-1477

2019

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Safety and activity of the TGFβ receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer

Journal for immunotherapy of cancer, 2021-03, Vol.9 (3), p.e002068

2021

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A phase Ib/II study of galunisertib in combination with nivolumab in solid tumors and non-small cell lung cancer

BMC cancer, 2023-07, Vol.23 (1), p.708-708, Article 708

2023

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Phase 1b study of galunisertib and ramucirumab in patients with advanced hepatocellular carcinoma

Cancer medicine (Malden, MA), 2021-05, Vol.10 (9), p.3059-3067

2021

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Donanemab exposure and efficacy relationship using modeling in Alzheimer's disease

Alzheimer's & dementia : translational research & clinical interventions, 2023-04, Vol.9 (2), p.e12404-n/a

2023

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Ethnic differences in the population pharmacokinetics and pharmacodynamics of warfarin

Journal of pharmacokinetics and pharmacodynamics, 2010-02, Vol.37 (1), p.3-24

2010

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Galunisertib plus gemcitabine vs. gemcitabine for first-line treatment of patients with unresectable pancreatic cancer

British journal of cancer, 2018-11, Vol.119 (10), p.1208-1214

2018

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Optimal design for multiresponse pharmacokinetic-pharmacodynamic models - dealing with unbalanced designs

Journal of pharmacokinetics and pharmacodynamics, 2007-06, Vol.34 (3), p.313-331

2007

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First-in-human dose study of the novel transforming growth factor-β receptor I kinase inhibitor LY2157299 monohydrate in patients with advanced cancer and glioma

Clinical cancer research, 2015-02, Vol.21 (3), p.553-560

2015

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A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma

Neuro-oncology (Charlottesville, Va.), 2016-08, Vol.18 (8), p.1146-1156

2016

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Phase II Study of the ALK5 Inhibitor Galunisertib in Very Low-, Low-, and Intermediate-Risk Myelodysplastic Syndromes

Clinical cancer research, 2019-12, Vol.25 (23), p.6976-6985

2019

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Models for change in tumour size, appearance of new lesions and survival probability in patients with advanced epithelial ovarian cancer

British journal of clinical pharmacology, 2016-09, Vol.82 (3), p.717-727

2016

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ACTR-16. PHASE 2 STUDY EVALUATING SAFETY, PHARMACOKINETICS (PK), PHARMACODYNAMICS (PD) AND EFFICACY OF THE ORAL TRANSFORMING GROWTH FACTOR-BETA (TGF-β) RECEPTOR I KINASE INHIBITOR GALUNISERTIB WHEN COMBINED WITH CHEMORADIOTHERAPY IN NEWLY DIAGNOSED MALIGNANT GLIOMA

Neuro-oncology (Charlottesville, Va.), 2016-11, Vol.18 (suppl_6), p.vi4-vi4

2016

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Fuzzy simulation of pharmacokinetic models: Case study of whole body physiologically based model of diazepam

Journal of pharmacokinetics and pharmacodynamics, 2004-06, Vol.31 (3), p.185-213

2004

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Randomized Phase 2 Studies of Checkpoint Inhibitors Alone or in Combination With Pegilodecakin in Patients With Metastatic NSCLC (CYPRESS 1 and CYPRESS 2)

Journal of thoracic oncology, 2021-02, Vol.16 (2), p.327-333

2021

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Pharmacokinetic, pharmacodynamic and biomarker evaluation of transforming growth factor-β receptor I kinase inhibitor, galunisertib, in phase 1 study in patients with advanced cancer

Investigational new drugs, 2015-04, Vol.33 (2), p.357-370

2015

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Mechanism for Enhanced Absorption of a Solid Dispersion Formulation of LY2300559 Using the Artificial Stomach Duodenum Model

Molecular pharmaceutics, 2015-04, Vol.12 (4), p.1131-1140

2015

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Incorporating measures of variability and uncertainty into the prediction of in vivo hepatic clearance from in vitro data

Drug metabolism and disposition, 2002-03, Vol.30 (3), p.276

2002

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Defining a therapeutic window for the novel TGF‐β inhibitor LY2157299 monohydrate based on a pharmacokinetic/pharmacodynamic model

British journal of clinical pharmacology, 2014-05, Vol.77 (5), p.796-807

2014

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A phase Ib dose-escalation and cohort-expansion study of safety and activity of the transforming growth factor (TGF) β receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer

Journal of clinical oncology, 2019-05, Vol.37 (15_suppl), p.4124-4124

2019

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Assessment of In Vivo Clinical Product Performance of a Weak Basic Drug by Integration of In Vitro Dissolution Tests and Physiologically Based Absorption Modeling

The AAPS journal, 2015-11, Vol.17 (6), p.1395-1406

2015

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A phase 2 study of galunisertib (TGF-Β R1 inhibitor) and sorafenib in patients with advanced hepatocellular carcinoma (HCC)

Journal of clinical oncology, 2017-05, Vol.35 (15_suppl), p.4097-4097

2017

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Population pharmacokinetic modelling of S-warfarin to evaluate the design of drug–drug interaction studies for CYP2C9

Journal of pharmacokinetics and pharmacodynamics, 2012-04, Vol.39 (2), p.147-160

2012

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A phase 2 study of galunisertib, a novel transforming growth factor-beta (TGF-β) receptor I kinase inhibitor, in patients with advanced hepatocellular carcinoma (HCC) and low serum alpha fetoprotein (AFP)

Journal of clinical oncology, 2016-05, Vol.34 (15_suppl), p.4070-4070

2016

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Phase 1b/2a study of galunisertib, a small molecule inhibitor of transforming growth factor-beta receptor I, in combination with standard temozolomide-based radiochemotherapy in patients with newly diagnosed malignant glioma

Novel transforming growth factor beta receptor I kinase inhibitor galunisertib (LY2157299) in advanced hepatocellular carcinoma

Safety and activity of the TGFβ receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer

A phase Ib/II study of galunisertib in combination with nivolumab in solid tumors and non-small cell lung cancer

Phase 1b study of galunisertib and ramucirumab in patients with advanced hepatocellular carcinoma

Donanemab exposure and efficacy relationship using modeling in Alzheimer's disease

Ethnic differences in the population pharmacokinetics and pharmacodynamics of warfarin

Galunisertib plus gemcitabine vs. gemcitabine for first-line treatment of patients with unresectable pancreatic cancer

Optimal design for multiresponse pharmacokinetic-pharmacodynamic models - dealing with unbalanced designs

First-in-human dose study of the novel transforming growth factor-β receptor I kinase inhibitor LY2157299 monohydrate in patients with advanced cancer and glioma

A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma

Phase II Study of the ALK5 Inhibitor Galunisertib in Very Low-, Low-, and Intermediate-Risk Myelodysplastic Syndromes

Models for change in tumour size, appearance of new lesions and survival probability in patients with advanced epithelial ovarian cancer

ACTR-16. PHASE 2 STUDY EVALUATING SAFETY, PHARMACOKINETICS (PK), PHARMACODYNAMICS (PD) AND EFFICACY OF THE ORAL TRANSFORMING GROWTH FACTOR-BETA (TGF-β) RECEPTOR I KINASE INHIBITOR GALUNISERTIB WHEN COMBINED WITH CHEMORADIOTHERAPY IN NEWLY DIAGNOSED MALIGNANT GLIOMA

Fuzzy simulation of pharmacokinetic models: Case study of whole body physiologically based model of diazepam

Randomized Phase 2 Studies of Checkpoint Inhibitors Alone or in Combination With Pegilodecakin in Patients With Metastatic NSCLC (CYPRESS 1 and CYPRESS 2)

Pharmacokinetic, pharmacodynamic and biomarker evaluation of transforming growth factor-β receptor I kinase inhibitor, galunisertib, in phase 1 study in patients with advanced cancer

Mechanism for Enhanced Absorption of a Solid Dispersion Formulation of LY2300559 Using the Artificial Stomach Duodenum Model

Incorporating measures of variability and uncertainty into the prediction of in vivo hepatic clearance from in vitro data

Defining a therapeutic window for the novel TGF‐β inhibitor LY2157299 monohydrate based on a pharmacokinetic/pharmacodynamic model

A phase Ib dose-escalation and cohort-expansion study of safety and activity of the transforming growth factor (TGF) β receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer

Assessment of In Vivo Clinical Product Performance of a Weak Basic Drug by Integration of In Vitro Dissolution Tests and Physiologically Based Absorption Modeling

A phase 2 study of galunisertib (TGF-Β R1 inhibitor) and sorafenib in patients with advanced hepatocellular carcinoma (HCC)

Population pharmacokinetic modelling of S-warfarin to evaluate the design of drug–drug interaction studies for CYP2C9

A phase 2 study of galunisertib, a novel transforming growth factor-beta (TGF-β) receptor I kinase inhibitor, in patients with advanced hepatocellular carcinoma (HCC) and low serum alpha fetoprotein (AFP)

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