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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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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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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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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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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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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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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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Abstract 2046: Exposure - response (overall survival OS) analyses of patients with unresectable pancreatic cancer (PC) treated with galunisertibgemcitabine (GG) or gemcitabineplacebo (GP) in a randomized phase 2, double-blind study

Cancer research (Chicago, Ill.), 2016-07, Vol.76 (14_Supplement), p.2046-2046

2016

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Abstract 2046: Exposure - response (overall survival [OS]) analyses of patients with unresectable pancreatic cancer (PC) treated with galunisertib+gemcitabine (GG) or gemcitabine+placebo (GP) in a randomized phase 2, double-blind study

Cancer research (Chicago, Ill.), 2016-07, Vol.76 (14_Supplement), p.2046-2046

2016

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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

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

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

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

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

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

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

Abstract 2046: Exposure - response (overall survival OS) analyses of patients with unresectable pancreatic cancer (PC) treated with galunisertibgemcitabine (GG) or gemcitabineplacebo (GP) in a randomized phase 2, double-blind study

Abstract 2046: Exposure - response (overall survival [OS]) analyses of patients with unresectable pancreatic cancer (PC) treated with galunisertib+gemcitabine (GG) or gemcitabine+placebo (GP) in a randomized phase 2, double-blind study

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