Oral AMXT 1501 Dicaprate in Combination With DFMO

Status Completed

Clinical Trial 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.

Clinical Trial Description

The objective of this study is to determine the safety and tolerability of oral AMXT 1501 dicaprate (AMXT1501) in combination with DFMO in patients with advanced solid tumors. Secondary objectives include characterization of plasma pharmacokinetics (PK) of AMXT 1501 as well as pharmacodynamic (PD) assessment of the impact of AMXT 1501 in combination with DFMO on polyamine uptake by circulating lymphocytes (blood cells). To these aims, the study will evaluate the safety, PK and PD profiles of orally-administered AMXT 1501 and DFMO. Approximately, 52 patients will be enrolled to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMXT 1501 and DFMO in combination. The MTD is defined as the highest dose level below at which dose escalation is stopped. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03536728
Study type	Interventional
Source	Aminex Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	June 12, 2018
Completion date	April 21, 2023

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