Galunisertib

Generic Name: Galunisertib

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₁₉N_₅O

CAS Number: 700874-72-2

Unique Ingredient Identifier: 3OKH1W5LZE

Background: Galunisertib has been used in trials studying the basic science and treatment of Glioma, Neoplasms, Solid Tumor, GLIOBLASTOMA, and Prostate Cancer, among others.

Clinical Trials

Galunisertib Combined With Capecitabine in Advanced CRC With PM

Phase 1

Recruiting

Conditions: Peritoneal Carcinomatosis
Colorectal Cancer Metastatic

Interventions: Drug: Galunisertib plus capecitabine

First Posted Date: 2023-01-26

Last Posted Date: 2024-07-22

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 31

Registration Number: NCT05700656

Locations: 🇳🇱
Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱
Amsterdam UMC, Amsterdam, Netherlands

Umbrella Biomarker-Guided Therapy in NPC

Phase 2

Not yet recruiting

Conditions: Nasopharyngeal Carcinoma

Interventions: Drug: GP+DDP
Radiation: Intensity-modulated radiotherapy
Drug: Palbociclib
Drug: PD-1 blocking antibody
Drug: Galunisertib

First Posted Date: 2020-10-28

Last Posted Date: 2021-09-05

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 206

Registration Number: NCT04605562

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

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

Phase 1

Withdrawn

Conditions: Colorectal Cancer Metastatic

Interventions: Drug: Galunisertib

First Posted Date: 2018-03-19

Last Posted Date: 2019-07-24

Lead Sponsor: The Netherlands Cancer Institute

Registration Number: NCT03470350

Locations: 🇳🇱
Antoni van Leeuwenhoek (NKI-AVL), Amsterdam, Noord-Holland, Netherlands

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

Phase 1

Completed

Conditions: Carcinosarcoma, Ovarian

Interventions: Drug: Galunisertib
Drug: Paclitaxel
Drug: Carboplatin

First Posted Date: 2017-07-02

Last Posted Date: 2024-08-07

Lead Sponsor: University of Oklahoma

Target Recruit Count: 26

Registration Number: NCT03206177

Locations: 🇺🇸
Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Galunisertib (LY2157299) Plus Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma (HCC)

Phase 1

Completed

Conditions: ADVANCED HEPATOCELLULAR CARCINOMA (HCC)

Interventions: Drug: Galunisertib 150mg by mouth twice a day
Radiation: Stereotactic Body Radiotherapy (SBRT)

First Posted Date: 2016-09-20

Last Posted Date: 2022-03-25

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 15

Registration Number: NCT02906397

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Study of Galunisertib in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Galunisertib

First Posted Date: 2016-04-27

Last Posted Date: 2016-07-04

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 40

Registration Number: NCT02752919

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician., Leeds, West Yorkshire, United Kingdom

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

Phase 1

Completed

Conditions: Metastatic Pancreatic Cancer

Interventions: Drug: Galunisertib
Drug: Durvalumab

First Posted Date: 2016-04-12

Last Posted Date: 2019-08-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 37

Registration Number: NCT02734160

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
🇮🇹
Ospedale Policlinico Giambattista Rossi, Borgo Roma, Verona, Italy
🇪🇸
Hospital Universitari Vall d'Hebron, Barcelona, Spain

and more 8 locations

ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer

Phase 2

Active, not recruiting

Conditions: Rectal Adenocarcinoma

Interventions: Drug: LY2157299
Drug: Capecitabine
Drug: Fluorouracil
Procedure: Tumor specific mesorectal excision

First Posted Date: 2016-02-23

Last Posted Date: 2025-03-10

Lead Sponsor: Providence Health & Services

Target Recruit Count: 50

Registration Number: NCT02688712

Locations: 🇺🇸
Providence Cancer Center, Portland, Oregon, United States

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

Phase 1

Completed

Conditions: Progesterone Receptor Negative
Triple-Negative Breast Carcinoma
HER2/Neu Negative
Estrogen Receptor Negative
Stage IV Breast Cancer
Recurrent Breast Carcinoma

Interventions: Drug: Galunisertib
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel

First Posted Date: 2016-02-03

Last Posted Date: 2023-11-22

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 29

Registration Number: NCT02672475

Locations: 🇺🇸
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Enzalutamide
Drug: LY2157299

First Posted Date: 2015-05-22

Last Posted Date: 2024-10-21

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 60

Registration Number: NCT02452008

Locations: 🇺🇸
Sibley Memorial Hospital, Washington, District of Columbia, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States

and more 1 locations

Drug Development Updates

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