9 completed, 9 recruiting, 2 active not recruiting, 1 available. 15 Phase 2, 11 Phase 1, 3 Phase 3, 1 Early Phase 1.
Follow DFMO: new trials by email Literature Review of DFMO trials Research Report on DFMO
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 |
|---|---|---|---|---|---|---|
| Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas Biospecimen Collection, Eflornithine, Lumbar Puncture - Anaplastic Oligodendroglioma, Astrocytoma, IDH-Mutant, Grade 3 | Phase 1 / Phase 2 | Recruiting | Mayo Clinic | 33 | 2026-06-23 | 2026-06-24 |
| Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma Eflornithine, Topotecan, Cyclophosphamide - Osteosarcoma, Ewing Sarcoma | Phase 2 | Recruiting | Milton S. Hershey Medical Center | 406 | 2026-06-05 | 2026-10-06 |
| Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors AMXT 1501 Dicaprate, DFMO, Fulvestrant - Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer | Phase 1 / Phase 2 | Recruiting | Aminex Therapeutics, Inc. | 92 | 2026-01-26 | 2026-10-22 |
| DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma DFMO - Osteosarcoma Recurrent, Ewing's Tumor Recurrent | Phase 1 / Phase 2 | Recruiting | Montefiore Medical Center | 15 | 2025-04-07 | 2026-05-14 |
| Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC (DFMO) Pembrolizumab, Difluoromethylornithine - Non Small Cell Lung Cancer, Lung Cancer | Phase 1 / Phase 2 | Suspended | H. Lee Moffitt Cancer Center and Research Institute | 45 | 2024-08-07 | 2026-03-06 |
| Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer DFMO, testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue - Prostate Cancer | Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 50 | 2023-10-04 | 2026-01-14 |
| Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma Biospecimen Collection, Computed Tomography, Eflornithine - Diffuse Glioma, Malignant Glioma | Early Phase 1 | Recruiting | Mayo Clinic | 18 | 2023-10-01 | 2025-11-04 |
| Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma Eflornithine (Dose Level 1), Eflornithine (Dose Level 2), Eflornithine (Dose Level -1) - Glioblastoma, IDH-wildtype, Glioblastoma | Phase 1 | Recruiting | Orbus Therapeutics, Inc. | 66 | 2023-07-24 | 2025-06-25 |
| TArgeting Type 1 Diabetes Using POLyamines (TADPOL) DFMO, Placebo - Type 1 Diabetes | Phase 2 | Active not recruiting | Emily K. Sims | 74 | 2023-03-14 | 2026-08-21 |
| Oral AMXT 1501 Dicaprate in Combination With IV DFMO AMXT1501, DFMO - Cancer, Solid Tumor | Phase 1 / Phase 2 | Terminated | Aminex Therapeutics, Inc. | 15 | 2022-11-29 | 2024-12-24 |
| DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma Difluoromethylornithine - Medulloblastoma | Phase 2 | Recruiting | Giselle Sholler | 118 | 2021-03-29 | 2026-08-12 |
| Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma Eflornithine - Neuroblastoma | Phase 2 | Active not recruiting | Giselle Sholler | 131 | 2020-09-25 | 2026-09-03 |
| Oral AMXT 1501 Dicaprate in Combination With DFMO AMXT1501, DFMO - Cancer, Solid Tumor | Phase 1 | Completed | Aminex Therapeutics, Inc. | 56 | 2018-06-12 | 2023-05-25 |
| Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients Eflornithine, Lomustine - Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma | Phase 3 | Unknown | Orbus Therapeutics, Inc. | 343 | 2016-07-01 | 2022-01-21 |
| Pediatric Precision Laboratory Advanced Neuroblastoma Therapy Ceritinib, dasatinib, sorafenib - Neuroblastoma | Phase 2 | Recruiting | Giselle Sholler | 500 | 2015-09-01 | 2026-09-04 |
| DFMO in Children With Type 1 Diabetes Difluoromethylornithine, Placebo - Type 1 Diabetes | Phase 1 | Completed | Indiana University | 41 | 2015-04-01 | 2021-09-05 |
| Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission DFMO - Neuroblastoma | Phase 2 | Completed | Giselle Sholler | 140 | 2015-03-05 | 2024-08-06 |
| Study of Difluoromethylornithine (DFMO) in Combination With Bortezomib for Relapsed or Refractory Neuroblastoma DFMO, Bortezomib - Neuroblastoma Recurrent | Phase 1 / Phase 2 | Completed | Giselle Sholler | 16 | 2014-06-06 | 2024-08-06 |
| N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan DFMO, Celecoxib, Cyclophosphamide - Neuroblastoma | Phase 1 | Completed | New Approaches to Neuroblastoma Therapy Consortium | 30 | 2014-01-16 | 2025-02-17 |
| A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP) Eflornithine plus Sulindac, Eflornithine plus Placebo, Sulindac plus Placebo - Familial Adenomatous Polyposis | Phase 3 | Withdrawn | Cancer Prevention Pharmaceuticals, Inc. | 2011-03-01 | 2015-04-24 |
Showing 20 of 25. Sign in to see all of them.
Neuroblastoma (6) · Glioma (4) · Astrocytoma (3) · Adenomatous Polyposis Coli (2) · Breast Neoplasms (2) · Carcinoma, Non-Small-Cell Lung (2) · Colorectal Neoplasms (2) · Diabetes Mellitus, Type 1 (2) · Glioblastoma (2) · Medulloblastoma (2) · Melanoma (2) · Neoplasms (2) · Adenomatous Polyps (1) · Brain Neoplasms (1) · Colonic Polyps (1)
Giselle Sholler (7) · Aminex Therapeutics, Inc. (3) · National Cancer Institute (NCI) (3) · Mayo Clinic (2) · Orbus Therapeutics, Inc. (2) · Cancer Prevention Pharmaceuticals, Inc. (1) · Emily K. Sims (1) · H. Lee Moffitt Cancer Center and Research Institute (1) · Indiana University (1) · Milton S. Hershey Medical Center (1) · Montefiore Medical Center (1) · New Approaches to Neuroblastoma Therapy Consortium (1) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (1)
United States (24) · Canada (5) · Australia (2) · Belgium (1) · France (1) · Germany (1) · Italy (1) · Netherlands (1) · United Kingdom (1)
Giselle Sholler, MD (4) · Terence C. Burns, MD, PhD (2) · Alfred M. Cohen, M.D. (1) · Alice Lee, MD (1) · Deyaa Adib, MD (1) · Emily K Sims, MD,MS (1) · Frank A Sinicrope (1) · Frank Meyskens (1) · Giselle Saulnier-Sholler, MD (1) · Giselle SaulnierSholler, MD (1) · Howard Colman, MD, PhD (1) · Jackie Walling, MBChB PhD (1) · Jhanelle E. Gray, M.D. (1) · Kathleen Neville, MD (1) · Laura Sena, MD, PhD (1)
PMID 32391579, PMID 10024506, PMID 10433086, PMID 10605821, PMID 10852253, PMID 11208527, PMID 11564949, PMID 11815483, PMID 12972423, PMID 15972654, PMID 16011702, PMID 16714282, PMID 17214730, PMID 1730582, PMID 17524725, PMID 18176934, PMID 18360702, PMID 19188144, PMID 19763038, PMID 19968980, PMID 19997760, PMID 20127992, PMID 20405312, PMID 20501948, PMID 20538001, PMID 20956533, PMID 21147316, PMID 21389784, PMID 22442300, PMID 23250488, PMID 25792707, PMID 26018967, PMID 26397425, PMID 2891995, PMID 3093066, PMID 3105526, PMID 3128541, PMID 32506485, PMID 32715853, PMID 34214479, PMID 34522028, PMID 37883734, PMID 37918404, PMID 38917371, PMID 40913836, PMID 41325560, PMID 431333, PMID 6422008, PMID 6781187, PMID 7895500
P01CA081403 (1), P30CA015083 (1), P30CA016672 (1), R01CA088078 (1), R01CA113681 (1), R37CA276851 (1)