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Spots Global Cancer Trial Database for Oral AMXT 1501 Dicaprate in Combination With DFMO

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Oral AMXT 1501 Dicaprate in Combination With DFMO

Official Title: Phase I Dose-Finding, Safety Study of Oral AMXT 1501 Dicaprate and Difluoromethylornithine (DFMO) in Patients With Advanced Solid Tumors

Study ID: NCT03536728

Interventions

AMXT1501
DFMO

Study Description

Brief 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.

Detailed 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.

Eligibility

Minimum Age: 12 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Next Oncology - Austin Midtown, Austin, Texas, United States

MD Anderson Cancer Center, Houston, Texas, United States

Next Oncology - San Antonio, San Antonio, Texas, United States

Virginia Cancer Center, Fairfax, Virginia, United States

Contact Details

Name: Nicole Gallegos, BS, MBA

Affiliation: Aminex

Role: STUDY_DIRECTOR

Name: Jackie Walling, MBChB PhD

Affiliation: Aminex

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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