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Oral AMXT 1501 Dicaprate in Combination With IV DFMO

NCT05500508 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-12-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Aminex Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sue Lee, MD · Aminex Therapeutics, Inc.

  • Michael Armstrong, MD · IQVIA Biotech

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-29
Primary Completion
2024-12-12
Completion
2024-12-12
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05500508 on ClinicalTrials.gov