2 recruiting, 1 completed, 1 terminated, 1 withdrawn. 5 Phase 1, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Recruiting 2, Completed 1, Terminated 1, Withdrawn 1 |
| Phase 2 | 3 | Recruiting 2, Terminated 1 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| Study of Orally-Administered AMXT 1501 Dicaprate in Normal Healthy Volunteers AMXT 1501, Placebo Oral Tablet - Neoplasms, Medication Toxicity | Phase 1 | Withdrawn | Aminex Therapeutics, Inc. | 2018-06-12 | 2018-06-14 | |
| 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 |
Neoplasms (3) · Breast Neoplasms (2) · Diffuse Intrinsic Pontine Glioma (2) · Melanoma (2) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Drug-Related Side Effects and Adverse Reactions (1) · Endometrial Neoplasms (1) · Esophageal Neoplasms (1) · Glioma (1) · Head and Neck Neoplasms (1) · Mesothelioma, Malignant (1) · Neuroblastoma (1) · Neuroectodermal Tumors, Primitive (1) · Osteosarcoma (1)
Eflornithine (2) · Fulvestrant (1) · capivasertib (1) · pembrolizumab (1)
United States (5) · Australia (1)
Deyaa Adib, MD (1) · Giselle Saulnier Sholler, MD (1) · Jackie Walling, MBChB PhD (1) · Michael Armstrong, MD (1) · Nicole Gallegos, BS, MBA (1) · Sue Lee, MD (1)