deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT05500508

Oral AMXT 1501 Dicaprate in Combination With IV DFMO

A Phase 1B/2A Study of the Safety, Tolerability and Initial Efficacy of Oral AMXT 1501 Dicaprate and Intravenous Difluoromethylornithine (DFMO) in Patients With Cancer

Sponsor: Aminex Therapeutics, Inc.

Conditions Advanced Cancer Breast Cancer Cancer Cervical Cancer Colorectal Cancer DIPG Brain Tumor Diffuse Midline Glioma, H3 K27M-Mutant Endometrial Cancer Esophageal Cancer Gastric Cancer Glioma, Malignant Head and Neck Cancer Melanoma Mesothelioma Peritoneum Mesotheliomas Pleural Nsclc Ovary Cancer Papillary Thyroid Cancer Solid Carcinoma Solid Tumor
Interventions AMXT1501 DFMO
Updated 11 times since 2022 Last updated: Dec 19, 2024 Started: Nov 29, 2022 Primary completion: Dec 12, 2024 Completion: Dec 12, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Required re-formulation of DFMO from IV to capsule to maintain safety

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Listed as NCT05500508, this PHASE1/PHASE2 trial focuses on Advanced Cancer and Breast Cancer and remains terminated or withdrawn. Sponsored by Aminex Therapeutics, Inc., it has been updated 11 times since 2022, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshotRecruiting~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshotRecruiting~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshotRecruiting~Apr 2023 – ~Jun 2023 · 2 months · monthly snapshotRecruiting~Jun 2023 – ~Sep 2023 · 3 months · monthly snapshotRecruiting~Sep 2023 – ~Nov 2023 · 2 months · monthly snapshotRecruiting~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshotSuspended~Oct 2024 – ~Jan 2025 · 3 months · monthly snapshotActive Not Recruiting~Jan 2025 – present · 18 months · monthly snapshotTerminated

Change History

11 versions recorded

  1. Jan 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

    Status: Active Not Recruiting → Terminated

  2. Oct 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Status: Suspended → Active Not Recruiting

  3. Sep 2024 — Oct 2024 [monthly]

    Suspended PHASE1/PHASE2

    Status: Recruiting → Suspended

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Nov 2023 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

▶ Show 6 earlier versions

  1. Sep 2023 — Nov 2023 [monthly]

    Recruiting PHASE1_PHASE2

  2. Jun 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

  3. Apr 2023 — Jun 2023 [monthly]

    Recruiting PHASE1_PHASE2

  4. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

  5. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE1_PHASE2

  6. Sep 2022 — Feb 2023 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Aminex Therapeutics, Inc.
Data source: Aminex Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations