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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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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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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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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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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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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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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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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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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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Abstract CT068: A randomized phase II, double-blind study to evaluate the efficacy and safety of galunisertib+gemcitabine (GG) or gemcitabine+placebo (GP) in patients with unresectable pancreatic cancer (PC)

Cancer research (Chicago, Ill.), 2016-07, Vol.76 (14_Supplement), p.CT068-CT068

2016

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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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A phase II, double-blind study of galunisertib+gemcitabine (GG) vs gemcitabine+placebo (GP) in patients (pts) with unresectable pancreatic cancer (PC)

Journal of clinical oncology, 2016-05, Vol.34 (15_suppl), p.4019-4019

2016

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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

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)

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

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

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

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

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

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

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

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

Abstract CT068: A randomized phase II, double-blind study to evaluate the efficacy and safety of galunisertib+gemcitabine (GG) or gemcitabine+placebo (GP) in patients with unresectable pancreatic cancer (PC)

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)

A phase II, double-blind study of galunisertib+gemcitabine (GG) vs gemcitabine+placebo (GP) in patients (pts) with unresectable pancreatic cancer (PC)

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