Trial Outcomes & Findings for Chemoprevention of Gastric Carcinogenesis (NCT NCT02794428)
NCT ID: NCT02794428
Last Updated: 2024-10-16
Results Overview
The cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX.The mean difference between the two groups at 6 months will be calculated, accounting for their baseline measurements.
COMPLETED
PHASE2
91 participants
at 6 months
2024-10-16
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
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
45 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Honduras
|
43 participants
n=99 Participants
|
43 participants
n=107 Participants
|
86 participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at 6 monthsThe cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX.The mean difference between the two groups at 6 months will be calculated, accounting for their baseline measurements.
Outcome measures
| Measure |
Eflornithine
n=32 Participants
Eflornithine: Eflornithine\*, 2 tablets, Oral, Daily for 18 months
|
Eflornithine Placebo
n=37 Participants
Eflornithine placebo: Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
|
|---|---|---|
|
The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months.
|
5.07 Percentage of positive cells
Standard Deviation 21.05
|
7.32 Percentage of positive cells
Standard Deviation 21.60
|
SECONDARY outcome
Timeframe: at 18 and 24 monthsThe cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX. The mean difference between the two groups at 18 and 24 months will be calculated, accounting for their baseline measurements.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 6, 18 and 24 monthsThe gastritis histopathology score is measured with a quantitative scale 0.0-6.0, for atrophy, intestinal metaplasia, and dysplasia. The mean differences between the two groups at 6, 18, and 24 months will be calculated using mixed models, accounting for their baseline measurements.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 6, 18, and 24 monthsToxicities will be assessed per CTCAE criteria, and each toxicity will be assigned an adverse event (AE) term according to CTCAE definitions (each AE term = unique representation of a specific event used for medical documentation and scientific analyses), and graded as defined by CTCAE (grade 1 = mild; grade 2 = moderate; grade 3 = severe or significant but not immediately life-threatening; grade 4 = life-threatening; grade 5 = death).
Outcome measures
Outcome data not reported
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
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.4%
2/45 • Number of events 2 • 24 months
|
6.5%
3/46 • Number of events 3 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place