Galunisertib

DRUG12 trials

Sponsors

Eli Lilly and Company, Vanderbilt-Ingram Cancer Center, University of Oklahoma, The Netherlands Cancer Institute, Sun Yat-sen University

Conditions

Carcinosarcoma, OvarianColorectal Cancer MetastaticEstrogen Receptor NegativeGlioblastomaHER2/Neu NegativeHealthyHepatocellular Carcinoma RecurrentMetastatic Pancreatic Cancer

Phase 1

A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer

CompletedNCT01373164

Eli Lilly and CompanyNeoplasm Metastasis, Neoplasms, Pancreatic Cancer

Start: 2011-06-30End: 2016-12-31Updated: 2018-05-16

A Study of Galunisertib on the Immune System in Participants With Cancer

CompletedNCT02304419

Eli Lilly and CompanyNeoplasm

Start: 2015-05-31End: 2016-08-31Updated: 2016-10-05

A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma

CompletedNCT02423343

Eli Lilly and CompanyHepatocellular Carcinoma Recurrent, Non-Small Cell Lung Cancer Recurrent, Solid Tumor

Start: 2015-01-01End: 2020-07-08Updated: 2021-09-09

Galunisertib and Paclitaxel in Treating Patients With Metastatic Androgen Receptor Negative (AR-) Triple Negative Breast Cancer

CompletedNCT02672475

Vanderbilt-Ingram Cancer CenterEstrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative +3

Start: 2016-03-31End: 2023-08-31Updated: 2023-11-22

A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer

CompletedNCT02734160

Eli Lilly and CompanyMetastatic Pancreatic Cancer

Start: 2016-06-15End: 2019-04-17Updated: 2019-08-05

Study of Galunisertib in Healthy Participants

CompletedNCT02752919

Eli Lilly and CompanyHealthy

Start: 2016-04-30End: 2016-06-30Updated: 2016-07-04

Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary

CompletedNCT03206177

University of OklahomaCarcinosarcoma, Ovarian

Start: 2017-08-23End: 2024-02-13Updated: 2024-08-07

Galunisertib and Capecitabine in Advanced Resistant TGF-beta Activated Colorectal Cancer

WithdrawnNCT03470350

The Netherlands Cancer InstituteColorectal Cancer Metastatic

Start: 2018-08-24End: 2020-06-01Updated: 2019-07-24

Phase 2

A Study in Recurrent Glioblastoma (GB)

CompletedNCT01582269

Eli Lilly and CompanyGlioblastoma

Start: 2012-04-26End: 2024-10-10Updated: 2025-11-24

A Study of Galunisertib in Participants With Myelodysplastic Syndromes

CompletedNCT02008318

Eli Lilly and CompanyMyelodysplastic Syndromes

Start: 2014-03-31End: 2017-09-30Updated: 2019-09-11

Phase I/II study with galunisertib (LY2157299) combined with capecitabine in patients with advanced chemotherapy resistant colorectal cancer and an activated TGF-* signature

Antoni van Leeuwenhoek Ziekenhuisbowel cancer colorectal carcinoma

Target: 10Updated: 2024-02-28

Umbrella Biomarker-Guided Therapy in NPC

Not yet recruitingNCT04605562

Sun Yat-sen UniversityNasopharyngeal Carcinoma

Start: 2022-06-30End: 2026-12-31Target: 206Updated: 2021-09-05

Related Papers

Feasibility IB trial of paclitaxel/carboplatin + Galunisertib. (a small molecule inhibitor of the kinase domain of type 1 TGF-B receptor) in patients with newly diagnosed, persistent or recurrent carcinosarcoma of the uterus or ovary.

2025-11-05

New advances in cancer therapy targeting TGF-β signaling pathways

Molecular Therapy — Oncolytics2023-12-0127 citations

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

2023-07-2845 citations

Signaling pathways in cancer-associated fibroblasts: recent advances and future perspectives.

2022-11-24186 citations

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 Cancer2021-03-01178 citations

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 Oncology2019-05-2028 citations

TGFβ receptor inhibitor galunisertib is linked to inflammation- and remodeling-related proteins in patients with pancreatic cancer.

2019-03-1883 citations

Abstract NG04: Immune evasion mechanisms in melanoma resistant to targeted- and/or immunotherapy

Cancer Research2018-07-01

Phase 1b dose-escalation and cohort-expansion study of the safety, tolerability, and efficacy of a novel transforming growth factor-β receptor I kinase inhibitor (galunisertib [G]) administered in combination with the anti-PD-L1 antibody (durvalumab [D]) in recurrent or refractory metastatic pancreatic cancer.

Journal of Clinical Oncology2017-02-013 citations

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 Oncology2016-05-2040 citations

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

Neuro-Oncology2016-02-21264 citations

A phase II study of galunisertib monotherapy or galunisertib plus lomustine compared to lomustine monotherapy in recurrent glioblastoma.

Journal of Clinical Oncology2015-05-206 citations