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DFMO

DRUG11 trials

Sponsors

Giselle Sholler, New Approaches to Neuroblastoma Therapy Consortium, Aminex Therapeutics, Inc., Emily K. Sims, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Conditions

Advanced CancerBreast CancerCancerCervical CancerColorectal CancerDIPG Brain TumorDiffuse Midline Glioma, H3 K27M-MutantEndometrial Cancer

Phase 1

Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide
CompletedNCT01059071
Giselle ShollerNeuroblastoma
Start: 2010-02-28End: 2015-05-31Updated: 2024-08-06
N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan
CompletedNCT02030964
New Approaches to Neuroblastoma Therapy ConsortiumNeuroblastoma
Start: 2014-01-16End: 2023-12-30Target: 30Updated: 2025-02-17
Study of Difluoromethylornithine (DFMO) in Combination With Bortezomib for Relapsed or Refractory Neuroblastoma
CompletedNCT02139397
Giselle ShollerNeuroblastoma Recurrent
Start: 2014-06-06End: 2024-01-19Updated: 2024-08-06
Oral AMXT 1501 Dicaprate in Combination With DFMO
CompletedNCT03536728
Aminex Therapeutics, Inc.Advanced Cancer, Cancer, Solid Carcinoma +1
Start: 2018-06-12End: 2023-04-21Updated: 2023-05-25
Oral AMXT 1501 Dicaprate in Combination With IV DFMO
TerminatedNCT05500508
Aminex Therapeutics, Inc.Advanced Cancer, Breast Cancer, Cancer +17
Start: 2022-11-29End: 2024-12-12Updated: 2024-12-24
DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma
RecruitingNCT06892678
Montefiore Medical CenterEwing's Tumor Recurrent, Osteosarcoma Recurrent
Start: 2025-04-07End: 2030-04-01Target: 15Updated: 2026-05-14
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
RecruitingNCT07287917
Aminex Therapeutics, Inc.HER2-low Hormone Receptor Positive Breast Cancer, Melanoma (Skin Cancer)
Start: 2026-01-26End: 2028-12-29Target: 92Updated: 2026-09-04

Phase 2

Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission
CompletedNCT02395666
Giselle ShollerNeuroblastoma
Start: 2015-03-05End: 2023-08-24Updated: 2024-08-06
Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
RecruitingNCT02559778
Giselle ShollerNeuroblastoma
Start: 2015-09-01End: 2035-09-01Target: 500Updated: 2026-09-04
TArgeting Type 1 Diabetes Using POLyamines (TADPOL)
Active, not recruitingNCT05594563
Emily K. SimsType 1 Diabetes
Start: 2023-03-14End: 2027-06-01Updated: 2026-08-21
Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
RecruitingNCT06059118
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsProstate Cancer
Start: 2023-10-04End: 2029-11-30Target: 50Updated: 2026-01-14

Related Papers

Phase I dose-escalation trial of AMXT 1501 dicaprate plus difluoromethylornithine: a dual-agent approach targeting immunosuppressive polyamine metabolism.
2025-09-061 citations
SCFA biotherapy delays diabetes in humanized gnotobiotic mice by remodeling mucosal homeostasis and metabolome.
2025-03-258 citations
MDB-61. STARVING TUMORS OF POLYAMINES: A NOVEL APPROACH IN TREATING AGGRESSIVE PEDIATRIC MEDULLOBLASTOMA
Neuro-Oncology2024-06-18
Survival outcomes in patients with high-risk neuroblastoma (HRNB) in remission after relapsed or refractory treatment receiving eflornithine (DFMO) maintenance.
Journal of Clinical Oncology2024-06-01
Abstract B047: Inhibition of the polyamine pathway: a novel therapeutic approach to treat aggressive pediatric medulloblastoma
Cancer Research2024-03-04
Phase 1 study of high-dose DFMO, celecoxib, cyclophosphamide and topotecan for patients with relapsed neuroblastoma: a New Approaches to Neuroblastoma Therapy trial.
2024-01-1011 citations
Abstract B132: Addition of AMXT1501 (polyamine uptake inhibitor) plus DFMO (polyamine synthesis inhibitor) to standard-of-care chemotherapy/anti-GD2 antibody in the TH-MYCN mouse neuroblastoma model, enhances efficacy compared to addition of DFMO alone
Molecular Cancer Therapeutics2023-12-011 citations
Inhibition of polyamine biosynthesis preserves β cell function in type 1 diabetes
Cell Reports Medicine2023-11-0122 citations
Eflornithine as Postimmunotherapy Maintenance in High-Risk Neuroblastoma: Externally Controlled, Propensity Score–Matched Survival Outcome Comparisons
Journal of Clinical Oncology2023-10-2657 citations
Matched external control analysis of event-free survival (EFS) in patients with high-risk neuroblastoma (HRNB) receiving eflornithine (DFMO) maintenance.
Journal of Clinical Oncology2022-06-012 citations
DIPG-15. POLYAMINE PATHWAY INHIBITION IS A POTENT NOVEL THERAPEUTIC STRATEGY AGAINST DIFFUSE INTRINSIC PONTINE GLIOMA
Neuro-Oncology2020-12-011 citations
NANT 2012-01: Phase 1 study of DFMO and celecoxib with cyclophosphamide and topotecan for relapsed or refractory high-risk neuroblastoma.
Journal of Clinical Oncology2018-05-203 citations