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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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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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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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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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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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Early change in tumour size predicts overall survival in patients with first-line metastatic breast cancer

European journal of cancer (1990), 2016-10, Vol.66, p.95-103

2016

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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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Investigating the impact of target lesion selection on drug effect evaluation and tumour growth rate determination using tumour growth inhibition models: Example of malignant pleural mesothelioma patients treated with cisplatin alone or in combination with pemetrexed

European journal of pharmaceutical sciences, 2021-06, Vol.161, p.105781-105781, Article 105781

2021

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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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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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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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Biomarker and Histopathology Evaluation of Patients with Recurrent Glioblastoma Treated with Galunisertib, Lomustine, or the Combination of Galunisertib and Lomustine

International journal of molecular sciences, 2017-05, Vol.18 (5), p.995

2017

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A program for individual and population optimal design for univariate and multivariate response pharmacokinetic–pharmacodynamic models

Computer methods and programs in biomedicine, 2007-04, Vol.86 (1), p.51-61

2007

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Linking preclinical and clinical whole-body physiologically based pharmacokinetic models with prior distributions in NONMEM

European journal of clinical pharmacology, 2007-05, Vol.63 (5), p.485-498

2007

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Pharmacokinetic modelling of interleukin‐1 receptor antagonist in plasma and cerebrospinal fluid of patients following subarachnoid haemorrhage

British journal of clinical pharmacology, 2008-03, Vol.65 (3), p.317-325

2008

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Diazepam pharamacokinetics from preclinical to phase I using a bayesian population physiologically based pharmacokinetic model with informative prior distributions in winbugs

Journal of pharmacokinetics and pharmacodynamics, 2006-10, Vol.33 (5), p.571-594

2006

Volltextzugriff (PDF)

Desipramine, substrate for CYP2D6 activity: population pharmacokinetic model and design elements of drug–drug interaction trials

British journal of clinical pharmacology, 2010-10, Vol.70 (4), p.523-536

2010

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The use of a modified Fedorov exchange algorithm to optimise sampling times for population pharmacokinetic experiments

Computer methods and programs in biomedicine, 2005-11, Vol.80 (2), p.115-125

2005

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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

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

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

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

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

Early change in tumour size predicts overall survival in patients with first-line metastatic breast cancer

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

Investigating the impact of target lesion selection on drug effect evaluation and tumour growth rate determination using tumour growth inhibition models: Example of malignant pleural mesothelioma patients treated with cisplatin alone or in combination with pemetrexed

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

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

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

Biomarker and Histopathology Evaluation of Patients with Recurrent Glioblastoma Treated with Galunisertib, Lomustine, or the Combination of Galunisertib and Lomustine

A program for individual and population optimal design for univariate and multivariate response pharmacokinetic–pharmacodynamic models

Linking preclinical and clinical whole-body physiologically based pharmacokinetic models with prior distributions in NONMEM

Pharmacokinetic modelling of interleukin‐1 receptor antagonist in plasma and cerebrospinal fluid of patients following subarachnoid haemorrhage

Diazepam pharamacokinetics from preclinical to phase I using a bayesian population physiologically based pharmacokinetic model with informative prior distributions in winbugs

Desipramine, substrate for CYP2D6 activity: population pharmacokinetic model and design elements of drug–drug interaction trials

The use of a modified Fedorov exchange algorithm to optimise sampling times for population pharmacokinetic experiments

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