5 recruiting, 4 active not recruiting, 4 completed, 4 terminated. 11 Phase 2, 8 Phase 1, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Active not recruiting 4, Terminated 3, Completed 2, Recruiting 2 |
| Phase 1 | 8 | Completed 4, Recruiting 3, Terminated 1 |
| Early Phase 1 | 1 | Recruiting 1 |
Follow ulixertinib: new trials by email Literature Review of ulixertinib trials Research Report on ulixertinib
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 |
|---|---|---|---|---|---|---|
| A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis Ulixertinib, Ruxolitinib - Myelofibrosis | Phase 1 / Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 37 | 2025-01-07 | 2026-07-28 |
| Ulixertinib in People With Histiocytic Neoplasms Ulixertinib - Histiocytic Neoplasms | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 38 | 2024-05-07 | 2026-10-15 |
| Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy Cetuximab, Ulixertinib, Encorafenib - Metastatic Colorectal Cancer | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 27 | 2024-01-18 | 2026-09-11 |
| Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas Ulixertinib - Gliomas | Early Phase 1 | Recruiting | M.D. Anderson Cancer Center | 40 | 2023-04-20 | 2026-06-12 |
| Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies Ulixertinib, Hydroxychloroquine - Tumor, Solid, Gastrointestinal Cancer | Phase 2 | Terminated | BioMed Valley Discoveries, Inc | 47 | 2022-05-26 | 2025-09-25 |
| Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations Ulixertinib, Physician's Choice - Advanced Solid Tumor, BRAF Gene Mutation | Phase 2 | Terminated | BioMed Valley Discoveries, Inc | 104 | 2021-01-07 | 2024-06-04 |
| Ulixertinib (BVD-523) and Hydroxychloroquine in Patients W Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas Ulixertinib, Hydroxychloroquine - Gastrointestinal Neoplasms | Phase 1 | Completed | University of Utah | 16 | 2020-03-17 | 2024-11-18 |
| Testing BVD-523FB (Ulixertinib) as Potentially Targeted Treatment in Cancers With Genetic Changes (MATCH - Subprotocol Z1L) Biopsy Procedure, Biospecimen Collection, Computed Tomography - Advanced Lymphoma, Advanced Malignant Solid Neoplasm | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 35 | 2019-07-24 | 2026-10-15 |
| Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) Pharmacokinetic Study, Ulixertinib - Advanced Malignant Solid Neoplasm, Recurrent Ependymal Tumor | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 20 | 2018-11-14 | 2026-09-21 |
| A Phase II Study of BVD-523 in Metastatic Uveal Melanoma BVD-523 - Uveal Melanoma | Phase 2 | Terminated | Dana-Farber Cancer Institute | 13 | 2018-03-26 | 2026-07-27 |
| Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors Ulixertinib, Palbociclib - Tumor, Solid, Pancreatic Cancer | Phase 1 | Recruiting | UNC Lineberger Comprehensive Cancer Center | 45 | 2018-01-30 | 2026-08-19 |
| Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration and Biopsy - Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 1377 | 2017-07-31 | 2026-07-24 |
| Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled BVD-523 in Volunteers [14C]-BVD-523 - Healthy | Phase 1 | Completed | BioMed Valley Discoveries, Inc | 6 | 2017-01-01 | 2019-06-17 |
| BVD-523 Plus Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer BVD-523, Nab-paclitaxel, Gemcitabine - Pancreatic Cancer, Cancer of Pancreas | Phase 1 | Terminated | Washington University School of Medicine | 18 | 2016-06-06 | 2021-04-21 |
| Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Adavosertib, Afatinib, Afatinib Dimaleate - Advanced Lymphoma, Advanced Malignant Solid Neoplasm | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 6452 | 2015-08-17 | 2026-10-26 |
| Phase 1/2 Study of the ERK1/2 Inhibitor BVD-523 in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndromes BVD-523 - Acute Myelogenous Leukemia, Myelodysplastic Syndrome | Phase 1 / Phase 2 | Completed | BioMed Valley Discoveries, Inc | 53 | 2014-11-01 | 2019-01-29 |
| Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies BVD-523 - Advanced Solid Tumors | Phase 1 / Phase 2 | Completed | BioMed Valley Discoveries, Inc | 136 | 2013-03-01 | 2020-03-20 |
| Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies Ulixertinib (BVD-523) - Pancreatic Cancer, Small Bowel Cancer | Available | xCures | 2026-06-04 |
Glioma (4) · Pancreatic Neoplasms (4) · Colorectal Neoplasms (3) · Melanoma (3) · Carcinoma, Hepatocellular (2) · Ependymoma (2) · Esophageal Neoplasms (2) · Gastrointestinal Neoplasms (2) · Hepatoblastoma (2) · Histiocytosis, Langerhans-Cell (2) · Lymphoma (2) · Lymphoma, Non-Hodgkin (2) · Medulloblastoma (2) · Multiple Myeloma (2) · Neoplasms (2)
BioMed Valley Discoveries, Inc (5) · National Cancer Institute (NCI) (4) · M.D. Anderson Cancer Center (2) · Memorial Sloan Kettering Cancer Center (2) · Dana-Farber Cancer Institute (1) · UNC Lineberger Comprehensive Cancer Center (1) · University of Utah (1) · Washington University School of Medicine (1) · xCures (1)
United States (17) · Puerto Rico (3) · Australia (1) · Canada (1) · Guam (1)
Christine Parseghian, MD (1) · Donald W Parsons (1) · Eli Diamond, MD (1) · F. Stephen Hodi, MD (1) · Irene Mirkin, MD (1) · Keith T Flaherty (1) · Kian-Huat Lim, M.D., Ph.D. (1) · Kieuhoa T Vo (1) · Nazanin Majd, MD (1) · Raajit Rampal, MD, PhD (1) · Stergios Moschos, MD (1) · Vivek Subbiah (1)
PMID 28939558, PMID 26586415, PMID 29603015, PMID 31401903, PMID 32463741, PMID 33048619, PMID 33389388, PMID 33591402, PMID 35133871, PMID 35138919, PMID 35353553, PMID 36351402, PMID 36427020, PMID 37053535, PMID 37322121, PMID 37934000, PMID 38591867, PMID 38935895, PMID 39666929, PMID 39693587, PMID 39913886, PMID 40865033, PMID 41066729, PMID 41166674, PMID 42686334
U10CA180820 (2), U10CA180886 (2), P50CA196510 (1), U24CA196172 (1)