Trials / Terminated
TerminatedNCT05500508
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
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Aminex Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 1B/2A study will be conducted to establish safety and dose level of AMXT 1501 dicaprate in combination with IV DFMO, in cancer patients.
Detailed description
The objective of this study is to determine the safety and tolerability of oral AMXT 1501 dicaprate (AMXT1501) in combination with IV DFMO in patients with advanced solid tumors, or DIPG/DMG. Secondary objectives include characterization of plasma pharmacokinetics (PK), pharmacodynamic (PD), and other biomarker efficacy assessments of the impact of AMXT 1501 in combination with IV DFMO on polyamine uptake by circulating lymphocytes (blood cells). To these aims, the study will evaluate the safety, PK, PD, and other biomarker efficacy profiles of orally-administered AMXT 1501 and IV DFMO. Approximately, 56 patients will be enrolled to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMXT 1501 and IV DFMO in combination. The MTD is defined as the highest dose level below at which dose escalation is stopped.
Conditions
- Cancer
- Solid Tumor
- Solid Carcinoma
- Advanced Cancer
- DIPG Brain Tumor
- Ovary Cancer
- Breast Cancer
- Papillary Thyroid Cancer
- Head and Neck Cancer
- Gastric Cancer
- Nsclc
- Mesotheliomas Pleural
- Mesothelioma Peritoneum
- Esophageal Cancer
- Diffuse Midline Glioma, H3 K27M-Mutant
- Endometrial Cancer
- Cervical Cancer
- Melanoma
- Colorectal Cancer
- Glioma, Malignant
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMXT1501 | AMXT 1501 dicaprate is D-lys(palmitoyl)-spermine dicaprate salt in 200 mg (free base content) enterically-coated capsules |
| DRUG | DFMO | DFMO is DL-2-(difluoromethyl) ornithine monohydrochloride monohydrate provided as a 200 mg/mL aqueous solution in 20 mL vials. |
Timeline
- Start date
- 2022-11-29
- Primary completion
- 2024-12-12
- Completion
- 2024-12-12
- First posted
- 2022-08-15
- Last updated
- 2024-12-24
Locations
7 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05500508. Inclusion in this directory is not an endorsement.