5 completed, 4 recruiting, 1 suspended, 1 terminated. 11 Phase 1, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 5, Recruiting 4, Suspended 1, Terminated 1 |
| Phase 2 | 6 | Recruiting 3, Completed 1, Suspended 1, Terminated 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| DFMO in Children With Type 1 Diabetes Difluoromethylornithine, Placebo - Type 1 Diabetes | Phase 1 | Completed | Indiana University | 41 | 2015-04-01 | 2021-09-05 |
| 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 |
| Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide DFMO, Etoposide - Neuroblastoma | Phase 1 | Completed | Giselle Sholler | 21 | 2010-02-01 | 2024-08-06 |
Astrocytoma (2) · Breast Neoplasms (2) · Carcinoma, Non-Small-Cell Lung (2) · Glioblastoma (2) · Glioma (2) · Melanoma (2) · Neoplasms (2) · Neuroblastoma (2) · Colorectal Neoplasms (1) · Diabetes Mellitus, Type 1 (1) · Diffuse Intrinsic Pontine Glioma (1) · Endometrial Neoplasms (1) · Esophageal Neoplasms (1) · Head and Neck Neoplasms (1) · Lung Neoplasms (1)
Aminex Therapeutics, Inc. (3) · Giselle Sholler (2) · H. Lee Moffitt Cancer Center and Research Institute (1) · Indiana University (1) · Mayo Clinic (1) · Montefiore Medical Center (1) · New Approaches to Neuroblastoma Therapy Consortium (1) · Orbus Therapeutics, Inc. (1)
United States (11) · Australia (2) · Canada (1)
Alice Lee, MD (1) · Deyaa Adib, MD (1) · Giselle Sholler, MD (1) · Howard Colman, MD, PhD (1) · Jackie Walling, MBChB PhD (1) · Jhanelle E. Gray, M.D. (1) · Kathleen Neville, MD (1) · Michael Armstrong, MD (1) · Michael Hogarty, MD (1) · Nicole Gallegos, BS, MBA (1) · Sue Lee, MD (1) · Terence C. Burns, MD, PhD (1)
PMID 26018967, PMID 32715853, PMID 37918404, PMID 40913836
P01CA081403 (1)