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Last Updated: July 31, 2021

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CLINICAL TRIALS PROFILE FOR GALUNISERTIB


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Clinical Trials for Galunisertib

Trial ID Title Status Sponsor Phase Summary
NCT02304419 ↗ A Study of Galunisertib on the Immune System in Participants With Cancer Completed Eli Lilly and Company Phase 1 The main purpose of this study is to learn more about how the study drug called galunisertib affects the immune system in participants with cancer. The study treatment is expected to last about six months for each participant, not including screening or follow-up.
NCT02423343 ↗ A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, Hepatocellular Carcinoma, or Glioblastoma Recruiting Bristol-Myers Squibb Phase 1/Phase 2 The main purpose of this study is to evaluate the safety, tolerability, and efficacy of the study drug known as galunisertib in combination with nivolumab in participants with advanced refractory solid tumors and in recurrent or refractory non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC) or glioblastoma.
NCT02423343 ↗ A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, Hepatocellular Carcinoma, or Glioblastoma Recruiting Eli Lilly and Company Phase 1/Phase 2 The main purpose of this study is to evaluate the safety, tolerability, and efficacy of the study drug known as galunisertib in combination with nivolumab in participants with advanced refractory solid tumors and in recurrent or refractory non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC) or glioblastoma.
NCT02452008 ↗ Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer Recruiting Sidney Kimmel Comprehensive Cancer Center Phase 2 The primary objective of this study is to compare the progression free survival (PFS) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).
NCT02672475 ↗ Galunisertib and Paclitaxel in Treating Patients With Metastatic Androgen Receptor Negative (AR-) Triple Negative Breast Cancer Recruiting National Cancer Institute (NCI) Phase 1 This phase I trial studies the side effects and best dose of Galunisertib when given together with paclitaxel in treating patients with androgen receptor negative or triple negative breast cancer that has spread to other places in the body. Some tumors need growth factors, which are made by the body's white blood cells, to keep growing. Galunisertib may interfere with growth factors and help cause tumor cells to die. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Galunisertib together with paclitaxel may kill more tumor cells.
NCT02672475 ↗ Galunisertib and Paclitaxel in Treating Patients With Metastatic Androgen Receptor Negative (AR-) Triple Negative Breast Cancer Recruiting Vanderbilt-Ingram Cancer Center Phase 1 This phase I trial studies the side effects and best dose of Galunisertib when given together with paclitaxel in treating patients with androgen receptor negative or triple negative breast cancer that has spread to other places in the body. Some tumors need growth factors, which are made by the body's white blood cells, to keep growing. Galunisertib may interfere with growth factors and help cause tumor cells to die. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Galunisertib together with paclitaxel may kill more tumor cells.
NCT02688712 ↗ ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer Not yet recruiting Eli Lilly and Company Phase 2 The purpose of this study is to see how effective and safe LY2157299, in combination with chemotherapy and radiation therapy, might be in treating rectal cancer. Also as part of this study, research will be done on tumor samples to see if it is possible to predict if patients will respond to treatment, and blood samples to look at the immune system response to study treatment. About 50 people will take part in this study. The study treatment will be given over an 8 week period and the investigators will continue to collect your health information for up to 5 years, as part of this study
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Galunisertib

Condition Name

Condition Name for
Intervention Trials
Prostate Cancer 1
Carcinosarcoma, Ovarian 1
HER2/Neu Negative 1
Progesterone Receptor Negative 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Carcinoma 4
Carcinoma, Hepatocellular 2
Adenocarcinoma 2
Glioblastoma 1
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Clinical Trial Locations for Galunisertib

Trials by Country

Trials by Country for
Location Trials
United States 15
Spain 2
China 1
Germany 1
Italy 1
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Trials by US State

Trials by US State for
Location Trials
Tennessee 2
New York 2
Oklahoma 1
Pennsylvania 1
Arizona 1
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Clinical Trial Progress for Galunisertib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 4
Phase 1/Phase 2 2
Phase 1 6
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 6
Not yet recruiting 4
Completed 2
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Clinical Trial Sponsors for Galunisertib

Sponsor Name

Sponsor Name for
Sponsor Trials
Eli Lilly and Company 8
University of Turin, Italy 1
National Cancer Institute (NCI) 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 15
Industry 11
NIH 1
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