18 completed, 3 active not recruiting, 2 not yet recruiting, 1 withdrawn. 16 Phase 1, 13 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 16 | Completed 14, Active not recruiting 1, Withdrawn 1 |
| Phase 2 | 13 | Completed 7, Active not recruiting 3, Not yet recruiting 2, Withdrawn 1 |
| Phase 3 | 2 | Completed 1, Not yet recruiting 1 |
Follow LY-2157299: new trials by email Literature Review of LY-2157299 trials Research Report on LY-2157299
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| This Study Evaluates the Safety, Target Engagement, and Preliminary Efficacy of Galunisertib (TGF-βR1/ALK5 Inhibitor)Combined With Nerandomilast (PDE4 Inhibitor) in GREM2-positive ALS, a Biomarker-defined Subgroup Hypothesized to Reflect Heightened TGF-β/SMAD-driven Astrocytic and Fibrotic Signaling Galunisertib + Nerandomilast Combination - ALS (Amyotrophic Lateral Sclerosis) | Phase 2 / Phase 3 | Not yet recruiting | Gipfel Life Sciences GmbH | 60 | 2026-06-30 | 2026-01-07 |
| Galunisertib Combined With Capecitabine in Advanced CRC With PM Galunisertib plus capecitabine - Colorectal Cancer Metastatic, Peritoneal Carcinomatosis | Phase 1 / Phase 2 | Active not recruiting | The Netherlands Cancer Institute | 31 | 2023-07-28 | 2026-07-13 |
| Umbrella Biomarker-Guided Therapy in NPC GP+DDP, Palbociclib, Intensity-modulated radiotherapy - Nasopharyngeal Carcinoma | Phase 2 | Not yet recruiting | Sun Yat-sen University | 206 | 2022-06-01 | 2021-09-05 |
| Galunisertib and Capecitabine in Advanced Resistant TGF-beta Activated Colorectal Cancer Galunisertib - Colorectal Cancer Metastatic | Phase 1 / Phase 2 | Withdrawn | The Netherlands Cancer Institute | 2018-08-24 | 2019-07-24 | |
| Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary Galunisertib, Paclitaxel, Carboplatin - Carcinosarcoma, Ovarian | Phase 1 | Completed | University of Oklahoma | 26 | 2017-08-23 | 2024-08-07 |
| Galunisertib (LY2157299) Plus Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma (HCC) Galunisertib 150mg by mouth twice a day, Stereotactic Body Radiotherapy (SBRT) - ADVANCED HEPATOCELLULAR CARCINOMA (HCC) | Phase 1 | Completed | Abramson Cancer Center at Penn Medicine | 15 | 2017-03-30 | 2022-03-25 |
| A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer Galunisertib, Durvalumab - Metastatic Pancreatic Cancer | Phase 1 | Completed | Eli Lilly and Company | 37 | 2016-06-15 | 2019-08-05 |
| Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer Enzalutamide, LY2157299 - Prostate Cancer | Phase 2 | Active not recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 60 | 2016-05-03 | 2025-12-19 |
| Study of Galunisertib in Healthy Participants Galunisertib - Healthy | Phase 1 | Completed | Eli Lilly and Company | 40 | 2016-04-01 | 2016-07-04 |
| ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer LY2157299, Capecitabine, Fluorouracil - Rectal Adenocarcinoma | Phase 2 | Active not recruiting | Providence Health & Services | 50 | 2016-03-24 | 2026-04-13 |
| Galunisertib and Paclitaxel in Treating Patients With Metastatic Androgen Receptor Negative (AR-) Triple Negative Breast Cancer Galunisertib, Laboratory Biomarker Analysis, Paclitaxel - Estrogen Receptor Negative, HER2/Neu Negative | Phase 1 | Completed | Vanderbilt-Ingram Cancer Center | 29 | 2016-03-01 | 2023-11-22 |
| A Study of Galunisertib on the Immune System in Participants With Cancer Galunisertib - Neoplasm | Phase 1 | Completed | Eli Lilly and Company | 10 | 2015-05-01 | 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 Galunisertib, Nivolumab - Solid Tumor, Non-Small Cell Lung Cancer Recurrent | Phase 1 / Phase 2 | Completed | Eli Lilly and Company | 41 | 2015-01-01 | 2021-09-09 |
| A Study of LY2157299 in Participants With Unresectable Hepatocellular Cancer (HCC) LY2157299, Sorafenib - Hepatocellular Carcinoma | Phase 1 | Completed | Eli Lilly and Company | 9 | 2014-11-12 | 2020-02-05 |
| A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma LY2157299, Sorafenib, Placebo - Hepatocellular Carcinoma | Phase 2 | Completed | Eli Lilly and Company | 132 | 2014-08-08 | 2022-02-25 |
| A Study of LY2157299 in Participants With Pancreatic Cancer That is Advanced or Has Spread to Another Part of the Body LY2157299, Gemcitabine - Pancreatic Neoplasms | Phase 1 | Completed | Eli Lilly and Company | 6 | 2014-05-01 | 2016-02-10 |
| A Study of Galunisertib in Participants With Myelodysplastic Syndromes Galunisertib, Placebo - Myelodysplastic Syndromes | Phase 2 / Phase 3 | Completed | Eli Lilly and Company | 43 | 2014-03-01 | 2019-09-11 |
| A Study of LY2157299 in Healthy Participants LY2157299 - Healthy Volunteers | Phase 1 | Completed | Eli Lilly and Company | 16 | 2013-10-01 | 2013-12-04 |
| Study of LY2157299 in Japanese Participants With Cancer LY2157299 - Neoplasms, Neoplasm Metastasis | Phase 1 | Completed | Eli Lilly and Company | 12 | 2012-11-01 | 2014-07-01 |
| A Study in Recurrent Glioblastoma (GB) Galunisertib, Lomustine, Placebo - Glioblastoma | Phase 2 | Completed | Eli Lilly and Company | 158 | 2012-04-26 | 2025-11-24 |
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Carcinoma, Hepatocellular (3) · Neoplasms (3) · Pancreatic Neoplasms (3) · Glioblastoma (2) · Glioma (2) · Neoplasm Metastasis (2) · Amyotrophic Lateral Sclerosis (1) · Breast Neoplasms (1) · Camurati-Engelmann Syndrome (1) · Carcinosarcoma (1) · Colorectal Neoplasms (1) · Myelodysplastic Syndromes (1) · Nasopharyngeal Carcinoma (1) · Peritoneal Neoplasms (1) · Prostatic Neoplasms (1)
Eli Lilly and Company (15) · The Netherlands Cancer Institute (2) · Abramson Cancer Center at Penn Medicine (1) · Gipfel Life Sciences GmbH (1) · Providence Health & Services (1) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (1) · Sun Yat-sen University (1) · University of Oklahoma (1) · Vanderbilt-Ingram Cancer Center (1)
United States (14) · Spain (8) · Germany (5) · Italy (5) · France (4) · Japan (3) · Netherlands (3) · Australia (2) · Belgium (2) · China (2) · South Korea (2) · Canada (1) · Hong Kong (1) · New Zealand (1) · Poland (1)
A Bardelli, Prof (1) · A Cervantes, Prof (1) · Channing Paller, MD (1) · F Ciardiello, Prof (1) · J Tabernero, Prof (1) · Kathleen Moore, MD (1) · Kim Reiss Binder, MD (1) · Kristina Young, MD, PhD (1) · R Bernards, Prof (1) · R Salazar, MD, PhD (1) · S Siena, Prof (1)
PMID 31903699, PMID 26526984, PMID 26632545, PMID 26902851, PMID 30887178, PMID 30963691, PMID 31481511, PMID 31995602, PMID 32140889, PMID 32210440, PMID 33688022, PMID 35405009, PMID 35952709, PMID 37507657
2015 (3), 2016 (1), P30CA068485 (1)