7 completed, 3 active not recruiting, 2 not yet recruiting, 1 withdrawn. 13 Phase 2, 5 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Completed 7, Active not recruiting 3, Not yet recruiting 2, Withdrawn 1 |
| Phase 1 | 5 | Completed 3, Active not recruiting 1, Withdrawn 1 |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Resistant TGF-beta Activated Colorectal Cancer Galunisertib - Colorectal Cancer Metastatic | Phase 1 / Phase 2 | Withdrawn | The Netherlands Cancer Institute | 2018-08-24 | 2019-07-24 | |
| 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 |
| 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 |
| 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 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 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 in Recurrent Glioblastoma (GB) Galunisertib, Lomustine, Placebo - Glioblastoma | Phase 2 | Completed | Eli Lilly and Company | 158 | 2012-04-26 | 2025-11-24 |
| A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer Galunisertib, Gemcitabine, Placebo - Neoplasms, Neoplasm Metastasis | Phase 1 / Phase 2 | Completed | Eli Lilly and Company | 170 | 2011-06-01 | 2018-05-16 |
| A Study Combining LY2157299 With Temozolomide-based Radiochemotherapy in Patients With Newly Diagnosed Malignant Glioma LY2157299, Radiation, Temozolomide - Glioma | Phase 1 / Phase 2 | Completed | Eli Lilly and Company | 75 | 2011-04-01 | 2017-02-16 |
| A Study of LY2157299 in Participants With Hepatocellular Carcinoma LY2157299, Sorafenib, Ramucirumab - Carcinoma, Hepatocellular | Phase 2 | Completed | Eli Lilly and Company | 204 | 2011-03-30 | 2021-01-12 |
Carcinoma, Hepatocellular (2) · Glioblastoma (2) · Amyotrophic Lateral Sclerosis (1) · Camurati-Engelmann Syndrome (1) · Colorectal Neoplasms (1) · Glioma (1) · Myelodysplastic Syndromes (1) · Nasopharyngeal Carcinoma (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Pancreatic Neoplasms (1) · Peritoneal Neoplasms (1) · Prostatic Neoplasms (1) · Rectal Neoplasms (1)
Eli Lilly and Company (7) · The Netherlands Cancer Institute (2) · Gipfel Life Sciences GmbH (1) · Providence Health & Services (1) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (1) · Sun Yat-sen University (1)
United States (7) · Spain (6) · Germany (5) · Italy (4) · France (3) · Netherlands (3) · Australia (2) · Belgium (2) · China (2) · Canada (1) · Hong Kong (1) · New Zealand (1) · Poland (1) · South Korea (1) · Taiwan (1)
A Bardelli, Prof (1) · A Cervantes, Prof (1) · Channing Paller, MD (1) · F Ciardiello, Prof (1) · J Tabernero, Prof (1) · Kristina Young, MD, PhD (1) · R Bernards, Prof (1) · R Salazar, MD, PhD (1) · S Siena, Prof (1) · S Tejpar, Prof (1) · Todd Crocenzi, MD (1)
PMID 31903699, PMID 26632545, PMID 26902851, PMID 30887178, PMID 30963691, PMID 31481511, PMID 31995602, PMID 32140889, PMID 32210440, PMID 35405009, PMID 35952709, PMID 37507657
2015 (1), 2016 (1)