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Oral AMXT 1501 Dicaprate in Combination With DFMO

NCT03536728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-05-25

No results posted yet for this study

Summary

A Phase 1 study will be conducted to establish safety and dose level of AMXT 1501 dicaprate alone, and in combination with DFMO, in cancer patients.

Conditions

Interventions

DRUG

AMXT1501

AMXT 1501 dicaprate is D-lys(palmitoyl)-spermine dicaprate salt in 40 mg or 200 mg (free base content) enterically-coated capsules

DRUG

DFMO

DFMO is DL-2-(difluoromethyl) ornithine monohydrochloride monohydrate 250 mg in hard gelatin capsules

Sponsors & Collaborators

  • Aminex Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Nicole Gallegos, BS, MBA · Aminex

  • Jackie Walling, MBChB PhD · Aminex

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2022-12-30
Completion
2023-04-21
FDA Drug
Yes

Countries

  • United States

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 NCT03536728 on ClinicalTrials.gov