CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 91 enrolled
Drug / intervention
Eflornithine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02794428
NCT02794428Phase 2Completed
CompareCT.gov

Targeted Chemoprevention of Gastric Carcinogenesis in High Risk Populations

Vanderbilt-Ingram Cancer Center·interventional·Posted Jun 9, 2016·Updated Oct 16, 2024

In Brief

A Phase 2 clinical trial evaluating Eflornithine and Eflornithine placebo for Gastric Cancer and Gastric Intestinal Metaplasia. Completed, enrolled 91 participants across 2 sites in 2 countries.

Detailed Summary

A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO) in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk regions of Latin America.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Gastric Intestinal Metaplasia
CountriesHonduras, Puerto Rico
CollaboratorsNational Cancer Institute (NCI), Cancer Prevention Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 9, 2016
Enrollment StartSep 19, 2016
Primary CompletionDec 20, 2022
Study CompletionJul 1, 2024
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 10.1 years ago

Interventions

Eflornithinedrug

Eflornithine\*, 2 tablets, Oral, Daily for 18 months

Eflornithine placeboother

Eflornithine placebo, 2 tablets, Oral, Daily for 18 months