Trial Outcomes & Findings for Chemoprevention of Gastric Carcinogenesis (NCT NCT02794428)
NCT ID: NCT02794428
Last Updated: 2026-09-02
Results Overview
The cell DNA damage is measured by the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences at 6 months versus baseline of the percent positive gastric epithelial cells is compared between the two groups.
COMPLETED
PHASE2
91 participants
Baseline up to 6 months
2026-09-02
Participant Flow
Participant milestones
| Measure |
Eflornithine
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
|---|---|---|
|
6 months (primary end point)
STARTED
|
45
|
46
|
|
6 months (primary end point)
COMPLETED
|
36
|
42
|
|
6 months (primary end point)
NOT COMPLETED
|
9
|
4
|
|
18 months (secondary endpoint)
STARTED
|
36
|
42
|
|
18 months (secondary endpoint)
COMPLETED
|
31
|
38
|
|
18 months (secondary endpoint)
NOT COMPLETED
|
5
|
4
|
|
24 months (end of study)
STARTED
|
31
|
38
|
|
24 months (end of study)
COMPLETED
|
26
|
29
|
|
24 months (end of study)
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemoprevention of Gastric Carcinogenesis
Baseline characteristics by cohort
| Measure |
Eflornithine
n=45 Participants
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
n=46 Participants
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=136 Participants
|
45 Participants
n=136 Participants
|
90 Participants
n=272 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=136 Participants
|
33 Participants
n=136 Participants
|
67 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=136 Participants
|
13 Participants
n=136 Participants
|
24 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=136 Participants
|
46 Participants
n=136 Participants
|
91 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
45 Participants
n=136 Participants
|
46 Participants
n=136 Participants
|
91 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=136 Participants
|
3 participants
n=136 Participants
|
5 participants
n=272 Participants
|
|
Region of Enrollment
Honduras
|
43 participants
n=136 Participants
|
43 participants
n=136 Participants
|
86 participants
n=272 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Only patients with evaluable IHC for gamma H2AX staining for DNA damage at both time points are included in this analysis. A central pathology review of pre- and post- intervention biopsy specimens was performed at Vanderbilt University for all DNA damage endpoints.
The cell DNA damage is measured by the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences at 6 months versus baseline of the percent positive gastric epithelial cells is compared between the two groups.
Outcome measures
| Measure |
Eflornithine
n=31 Participants
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
n=34 Participants
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
|---|---|---|
|
Gastric Epithelial Cell DNA Damage, at 6 Months Versus Baseline
|
4.93 %positive gastric epithelial cells
Standard Deviation 21.38
|
4.31 %positive gastric epithelial cells
Standard Deviation 19.50
|
SECONDARY outcome
Timeframe: Baseline up to 18 monthsPopulation: Only patients with evaluable IHC for gamma H2AX staining for DNA damage at both time points are included in this analysis. A central pathology review of pre- and post- intervention biopsy specimens was performed at Vanderbilt University for all DNA damage endpoints.
The cell DNA damage is measured using the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences in percent positive gastric epithelial cells at 18 months versus baseline is compared between the two groups.
Outcome measures
| Measure |
Eflornithine
n=27 Participants
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
n=34 Participants
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
|---|---|---|
|
Gastric Epithelial Cell DNA Damage, at 18 Months Versus Baseline
|
6.30 %positive gastric epithelial cells
Standard Deviation 22.26
|
-0.20 %positive gastric epithelial cells
Standard Deviation 19.62
|
SECONDARY outcome
Timeframe: Baseline up to 24 monthsPopulation: Only patients with evaluable IHC for gamma H2AX staining for DNA damage at both time points are included in this analysis. A central pathology review of pre- and post- intervention biopsy specimens was performed at Vanderbilt University for all DNA damage endpoints.
The cell DNA damage is measured by the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences at 24 months versus baseline of the percent positive gastric epithelial cells is compared between the two groups.
Outcome measures
| Measure |
Eflornithine
n=23 Participants
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
n=26 Participants
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
|---|---|---|
|
Gastric Epithelial Cell DNA Damage, at 24 Months Versus Baseline
|
-5.78 %positive gastric epithelial cells
Standard Deviation 30.13
|
-0.13 %positive gastric epithelial cells
Standard Deviation 28.50
|
SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: A central pathology review of pre- and post- intervention biopsy specimens was performed at Vanderbilt University for all histology score endpoints.
The mean differences in the gastric histopathology score at 6 months versus baseline are calculated, with comparison of the eflornithine and placebo groups. The changes in histology stage are assessed with the validated Correa Histopathology Score system (ranges represent differences in severity and extent): normal mucosa 1, non-atrophic gastritis 2, multifocal atrophic gastritis without intestinal metaplasia 3.25-4.0, gastric intestinal metaplasia 4.3-5.0, dysplasia 5.25-5.75, and cancer 6. The Correa Histopathology Score is based upon the Updated Sydney System biopsy protocol (5 biopsies). The most advanced lesion (highest Correa score) in the stomach represents the summary Correa score for the patient at the given time point.
Outcome measures
| Measure |
Eflornithine
n=34 Participants
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
n=38 Participants
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
|---|---|---|
|
Change in Gastric Histopathology Score, at 6 Months Versus Baseline
|
-0.14 Correa Histopathology Score on a scale
Standard Deviation 0.55
|
-0.18 Correa Histopathology Score on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Baseline up to 18 monthsPopulation: A central pathology review of pre- and post- intervention biopsy specimens was performed at Vanderbilt University for all histology score endpoints.
The mean differences in the gastric histopathology score at 18 months versus baseline are calculated, with comparison of the eflornithine and placebo groups. The changes in histology stage are assessed with the validated Correa Histopathology Score system (ranges represent differences in severity and extent): normal mucosa 1, non-atrophic gastritis 2, multifocal atrophic gastritis without intestinal metaplasia 3.25-4.0, gastric intestinal metaplasia 4.3-5.0, dysplasia 5.25-5.75, and cancer 6. The Correa Histopathology Score is based upon the Updated Sydney System biopsy protocol (5 biopsies). The most advanced lesion (highest Correa score) in the stomach represents the summary Correa score for the patient at the given time point.
Outcome measures
| Measure |
Eflornithine
n=31 Participants
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
n=36 Participants
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
|---|---|---|
|
Change in Gastric Histology Score, at 18 Months Versus Baseline
|
-0.16 Correa Histopathology Score on a scale
Standard Deviation 0.60
|
-0.24 Correa Histopathology Score on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Baseline up to 24 monthsPopulation: A central pathology review of pre- and post- intervention biopsy specimens was performed at Vanderbilt University for all histology score endpoints.
The mean differences in the gastric histopathology score at 24 months versus baseline are calculated, with comparison of the eflornithine and placebo groups. The changes in histology stage are assessed with the validated Correa Histopathology Score system (ranges represent differences in severity and extent): normal mucosa 1, non-atrophic gastritis 2, multifocal atrophic gastritis without intestinal metaplasia 3.25-4.0, gastric intestinal metaplasia 4.3-5.0, dysplasia 5.25-5.75, and cancer 6. The Correa Histopathology Score is based upon the Updated Sydney System biopsy protocol (5 biopsies). The most advanced lesion (highest Correa score) in the stomach represents the summary Correa score for the patient at the given time point.
Outcome measures
| Measure |
Eflornithine
n=26 Participants
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
n=27 Participants
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
|---|---|---|
|
Change in Gastric Histology Score, at 24 Months Versus Baseline
|
-0.34 Correa Histopathology Score on a scale
Standard Deviation 0.58
|
-0.32 Correa Histopathology Score on a scale
Standard Deviation 0.68
|
Adverse Events
Eflornithine
Eflornithine Placebo
Serious adverse events
| Measure |
Eflornithine
n=45 participants at risk
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
n=46 participants at risk
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
|---|---|---|
|
Cardiac disorders
Hypertensive urgency
|
0.00%
0/45 • 24 months
|
2.2%
1/46 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/45 • 24 months
|
2.2%
1/46 • Number of events 1 • 24 months
|
|
Infections and infestations
COVID-19
|
2.2%
1/45 • Number of events 1 • 24 months
|
0.00%
0/46 • 24 months
|
|
Gastrointestinal disorders
Diverticulitis
|
2.2%
1/45 • Number of events 1 • 24 months
|
0.00%
0/46 • 24 months
|
Other adverse events
| Measure |
Eflornithine
n=45 participants at risk
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
n=46 participants at risk
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
|---|---|---|
|
Ear and labyrinth disorders
Hearing impaired
|
8.9%
4/45 • Number of events 4 • 24 months
|
6.5%
3/46 • Number of events 3 • 24 months
|
|
Ear and labyrinth disorders
Tinnitus
|
8.9%
4/45 • Number of events 4 • 24 months
|
2.2%
1/46 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
5/45 • Number of events 10 • 24 months
|
10.9%
5/46 • Number of events 7 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
4.4%
2/45 • Number of events 3 • 24 months
|
15.2%
7/46 • Number of events 9 • 24 months
|
|
Infections and infestations
Vaginal infection
|
6.7%
3/45 • Number of events 3 • 24 months
|
4.3%
2/46 • Number of events 2 • 24 months
|
|
Investigations
Alanine aminotransferase increased
|
4.4%
2/45 • Number of events 3 • 24 months
|
21.7%
10/46 • Number of events 12 • 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
4.4%
2/45 • Number of events 2 • 24 months
|
13.0%
6/46 • Number of events 6 • 24 months
|
|
Investigations
Blood bilirubin increased
|
4.4%
2/45 • Number of events 2 • 24 months
|
13.0%
6/46 • Number of events 7 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
2/45 • Number of events 3 • 24 months
|
8.7%
4/46 • Number of events 5 • 24 months
|
|
Nervous system disorders
Dizziness
|
6.7%
3/45 • Number of events 3 • 24 months
|
4.3%
2/46 • Number of events 2 • 24 months
|
|
Nervous system disorders
Headache
|
15.6%
7/45 • Number of events 8 • 24 months
|
13.0%
6/46 • Number of events 7 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place