15 completed, 8 recruiting, 4 active not recruiting, 1 suspended. 30 Phase 2, 6 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 30 | Completed 15, Recruiting 8, Active not recruiting 4, Suspended 1, Terminated 1, Withdrawn 1 |
| Phase 1 | 6 | Recruiting 4, Completed 1, Suspended 1 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
Follow Eflornithine: new trials by email Literature Review of Eflornithine trials Research Report on Eflornithine
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 |
| Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas Eflornithine (DFMO), AMXT 1501 Dicaprate - Atypical Teratoid/Rhabdoid Tumor, Embryonal Tumor With Multilayered Rosettes | Phase 1 / Phase 2 | Recruiting | Milton S. Hershey Medical Center | 265 | 2026-05-13 | 2026-09-03 |
| 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 |
| Randomized Split-Face Controlled Study to Evaluate the Effectiveness of Topical Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% as Compared to Topical Tretinoin 0.05% + Hydroquinone 4% + Fluocinolone 0.01% for the Treatment of Melasma Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream, Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream - Melasma, Melasma (Facial Melasma) | Phase 2 | Completed | National Skin Centre | 30 | 2023-06-06 | 2026-10-15 |
| 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 |
| 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 |
| Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer Solaraze and Vaniqa - Non-melanoma Skin Cancer | Phase 2 | Completed | University of Alabama at Birmingham | 64 | 2021-01-18 | 2025-12-17 |
| Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma Eflornithine - Neuroblastoma | Phase 2 | Active not recruiting | Giselle Sholler | 131 | 2020-09-25 | 2026-09-03 |
| Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma Dinutuximab, Eflornithine Hydrochloride, Irinotecan Hydrochloride - High Risk Neuroblastoma, Recurrent Neuroblastoma | Phase 2 | Active not recruiting | Children's Oncology Group | 94 | 2019-07-08 | 2026-02-18 |
| Chemoprevention of Gastric Carcinogenesis Eflornithine, Eflornithine placebo - Gastric Cancer, Gastric Intestinal Metaplasia | Phase 2 | Completed | Vanderbilt-Ingram Cancer Center | 91 | 2016-09-19 | 2026-09-02 |
| Neuroblastoma Maintenance Therapy Trial Difluoromethylornithine (DFMO) - Neuroblastoma | Phase 2 | Active not recruiting | Giselle Sholler | 441 | 2016-02-01 | 2026-09-03 |
| Pediatric Precision Laboratory Advanced Neuroblastoma Therapy Ceritinib, dasatinib, sorafenib - Neuroblastoma | Phase 2 | Recruiting | Giselle Sholler | 500 | 2015-09-01 | 2026-09-04 |
| 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 |
| Urinary Biomarker Study With Sulindac and Difluoromethylornithine difluoromethylornithine, Sulindac - Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms | Phase 2 | Withdrawn | Cancer Prevention Pharmaceuticals, Inc. | 2014-03-01 | 2014-07-30 | |
| Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2 Fexinidazole, Nifurtimox, Eflornithine - Human African Trypanosomiasis (HAT), Sleeping Sickness | Phase 2 / Phase 3 | Completed | Drugs for Neglected Diseases | 394 | 2012-10-01 | 2018-02-20 |
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Neuroblastoma (6) · Prostatic Neoplasms (3) · Osteosarcoma (2) · Precancerous Conditions (2) · Sarcoma, Ewing (2) · Skin Neoplasms (2) · Trypanosomiasis, African (2) · Adenomatous Polyposis Coli (1) · Adenomatous Polyps (1) · Astrocytoma (1) · Breast Neoplasms (1) · Carcinoma, Basal Cell (1) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Diabetes Mellitus, Type 1 (1)
Giselle Sholler (6) · Milton S. Hershey Medical Center (2) · National Cancer Institute (NCI) (2) · University of Alabama at Birmingham (2) · University of Arizona (2) · Aminex Therapeutics, Inc. (1) · Cancer Prevention Pharmaceuticals, Inc. (1) · Children's Oncology Group (1) · Drugs for Neglected Diseases (1) · Emily K. Sims (1) · Epicentre (1) · H. Lee Moffitt Cancer Center and Research Institute (1) · M.D. Anderson Cancer Center (1) · Mayo Clinic (1) · Montefiore Medical Center (1)
United States (24) · Canada (5) · Puerto Rico (2) · Australia (1) · Central African Republic (1) · Democratic Republic of the Congo (1) · Honduras (1) · New Zealand (1) · Republic of the Congo (1) · Singapore (1) · Uganda (1)
Giselle Sholler, MD (3) · Alice Lee, MD (1) · Craug Elmets, MD (1) · David S. Alberts, MD (1) · Dean E. Brenner, MD (1) · Deyaa Adib, MD (1) · Donald A. Urban, MD (1) · Doug Morgan, MD (1) · Emily K Sims, MD,MS (1) · Frank A Sinicrope (1) · Gerardo Priotto, MD MPH (1) · Giselle Saulnier Sholler, MD (1) · Giselle Saulnier-Sholler, MD (1) · Giselle SaulnierSholler, MD (1) · Howard H Bailey, MD (1)
PMID 32391579, PMID 38917371, 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 18268112, PMID 18360702, PMID 19188144, PMID 19763038, PMID 19968980, PMID 19997760, PMID 20127992, PMID 20405312, PMID 20501948, PMID 20956533, PMID 21147316, PMID 21389784, PMID 22442300, PMID 23250488, PMID 25792707, PMID 26397425, PMID 26712942, PMID 2891995, PMID 29113731, PMID 3093066, PMID 3105526, PMID 3128541, PMID 32506485, PMID 34214479, PMID 34522028, PMID 37883734, PMID 38200233, PMID 41801147, PMID 431333, PMID 6422008, PMID 6781187, PMID 7895500, PMID 8262968
P01CA027502 (2), P30CA016672 (2), P30CA015083 (1), P30CA023074 (1), P30CA046592 (1), R01CA113681 (1), R01CA190612 (1), R01CA193885 (1), U10CA180886 (1)