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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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Clinical development of galunisertib (LY2157299 monohydrate), a small molecule inhibitor of transforming growth factor-beta signaling pathway

Drug design, development and therapy, 2015-01, Vol.9 (default), p.4479-4499

2015

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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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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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Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA)

Journal of clinical oncology, 2021-04, Vol.39 (10), p.1108-1118

2021

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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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Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease

Clinical pharmacology and therapeutics, 2023-06, Vol.113 (6), p.1258-1267

2023

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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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Donanemab exposure‐efficacy relationship in patients with early symptomatic Alzheimer’s disease

Alzheimer's & dementia, 2023-06, Vol.19 (S7), p.n/a

2023

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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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Disease progression model using the integrated Alzheimer's Disease Rating Scale

Alzheimer's & dementia, 2023-06, Vol.19 (6), p.2253-2264

2023

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Amyloid re‐accumulation after donanemab treatment: summary from 3 interventional trials

Alzheimer's & dementia, 2023-12, Vol.19 (S14), p.n/a

2023

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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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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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Disposition and metabolism of [14C]-galunisertib, a TGF-βRI kinase/ALK5 inhibitor, following oral administration in healthy subjects and mechanistic prediction of the effect of itraconazole on galunisertib pharmacokinetics

Xenobiotica, 2018-04, Vol.48 (4), p.382-399

2018

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

Clinical development of galunisertib (LY2157299 monohydrate), a small molecule inhibitor of transforming growth factor-beta signaling pathway

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

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

Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA)

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

Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease

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

Donanemab exposure‐efficacy relationship in patients with early symptomatic Alzheimer’s disease

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

Disease progression model using the integrated Alzheimer's Disease Rating Scale

Amyloid re‐accumulation after donanemab treatment: summary from 3 interventional trials

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)

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

Disposition and metabolism of [14C]-galunisertib, a TGF-βRI kinase/ALK5 inhibitor, following oral administration in healthy subjects and mechanistic prediction of the effect of itraconazole on galunisertib pharmacokinetics

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

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