A Phase 2 interventional study of Eflornithine and Eflornithine placebo in Gastric Cancer and Gastric Intestinal Metaplasia, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 2 sites in 2 countries. Open to participants aged 30 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Prevention
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.
Primary Objective
- The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo at 6 months. 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.
Secondary Objectives
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's enrollment of 91 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 223 studies on the registry; 33 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must have adequate blood counts as evidenced by the following results (obtained within 60 days):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Eflornithine
Other: Eflornithine placebo
Eflornithine\*, 2 tablets, Oral, Daily for 18 months
Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
Gastric Epithelial Cell DNA Damage, at 6 Months Versus Baseline
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.
Time frame: Baseline up to 6 months
Gastric Epithelial Cell DNA Damage, at 18 Months Versus Baseline
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.
Time frame: Baseline up to 18 months
Gastric Epithelial Cell DNA Damage, at 24 Months Versus Baseline
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.
Time frame: Baseline up to 24 months
Change in Gastric Histopathology Score, at 6 Months Versus Baseline
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.
Time frame: Baseline up to 6 months
Change in Gastric Histology Score, at 18 Months Versus Baseline
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.
Time frame: Baseline up to 18 months
Change in Gastric Histology Score, at 24 Months Versus Baseline
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.
Time frame: Baseline up to 24 months
| Milestone | Eflornithine | Eflornithine Placebo |
|---|---|---|
| Started | 45 | 46 |
| Completed | 36 | 42 |
| Not completed | 9 | 4 |
| Milestone | Eflornithine | Eflornithine Placebo |
|---|---|---|
| Started | 36 | 42 |
| Completed | 31 | 38 |
| Not completed | 5 | 4 |
| Milestone | Eflornithine | Eflornithine Placebo |
|---|---|---|
| Started | 31 | 38 |
| Completed | 26 | 29 |
| Not completed | 5 | 9 |
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.
| %positive gastric epithelial cells | Eflornithine | Eflornithine Placebo |
|---|---|---|
| Gastric Epithelial Cell DNA Damage, at 6 Months Versus Baseline | 4.93 ± 21.38 | 4.31 ± 19.50 |
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.
| %positive gastric epithelial cells | Eflornithine Follow up 18 Months | Eflornithine Placebo Follow Up 18 Months |
|---|---|---|
| Gastric Epithelial Cell DNA Damage, at 18 Months Versus Baseline | 6.30 ± 22.26 | -0.20 ± 19.62 |
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.
| %positive gastric epithelial cells | Eflornithine | Eflornithine Placebo |
|---|---|---|
| Gastric Epithelial Cell DNA Damage, at 24 Months Versus Baseline | -5.78 ± 30.13 | -0.13 ± 28.50 |
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.
| Correa Histopathology Score on a scale | Eflornithine Follow up 6 Months | Eflornithine Placebo Follow up 6 Months |
|---|---|---|
| Change in Gastric Histopathology Score, at 6 Months Versus Baseline | -0.14 ± 0.55 | -0.18 ± 0.57 |
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.
| Correa Histopathology Score on a scale | Eflornithine at Follow up 18 Months | Eflornithine Placebo at Follow up 18 Months |
|---|---|---|
| Change in Gastric Histology Score, at 18 Months Versus Baseline | -0.16 ± 0.60 | -0.24 ± 0.68 |
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.
| Correa Histopathology Score on a scale | Eflornithine Follow Up 24 Months | Eflornithine Placebo Follow up 24 Months |
|---|---|---|
| Change in Gastric Histology Score, at 24 Months Versus Baseline | -0.34 ± 0.58 | -0.32 ± 0.68 |
Collected over 24 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eflornithine | 0/45 (0%) | 2/45 (4.4%) | 23/45 (51.1%) |
| Eflornithine Placebo | 0/46 (0%) | 2/46 (4.3%) | 32/46 (69.6%) |
| Event | Eflornithine | Eflornithine Placebo |
|---|---|---|
| COVID-19Infections and infestations | 1/45 | 0/46 |
| DiverticulitisGastrointestinal disorders | 1/45 | 0/46 |
| Hypertensive urgencyCardiac disorders | 0/45 | 1/46 |
| AppendicitisGastrointestinal disorders | 0/45 | 1/46 |
| Event | Eflornithine | Eflornithine Placebo |
|---|---|---|
| Alanine aminotransferase increasedInvestigations | 2/45 | 10/46 |
| HeadacheNervous system disorders | 7/45 | 6/46 |
| DiarrheaGastrointestinal disorders | 2/45 | 7/46 |
| Aspartate aminotransferase increasedInvestigations | 2/45 | 6/46 |
| Blood bilirubin increasedInvestigations | 2/45 | 6/46 |
| Abdominal painGastrointestinal disorders | 5/45 | 5/46 |
| Hearing impairedEar and labyrinth disorders | 4/45 | 3/46 |
| TinnitusEar and labyrinth disorders | 4/45 | 1/46 |
| Back painMusculoskeletal and connective tissue disorders | 2/45 | 4/46 |
| Vaginal infectionInfections and infestations | 3/45 | 2/46 |
| Age, Categorical(Participants) | Eflornithine | Eflornithine Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 45 | 90 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Eflornithine | Eflornithine Placebo | Total |
|---|---|---|---|
| Female | 34 | 33 | 67 |
| Male | 11 | 13 | 24 |
| Ethnicity (NIH/OMB)(Participants) | Eflornithine | Eflornithine Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 45 | 46 | 91 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Eflornithine | Eflornithine Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 45 | 46 | 91 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Eflornithine | Eflornithine Placebo | Total |
|---|---|---|---|
| Puerto Rico | 2 | 3 | 5 |
| Honduras | 43 | 43 | 86 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2016 to primary completion in Dec 2022, 75 months.
Results were first posted in Apr 2024, 1 year 3 months after primary completion.
Of 293 non-industry phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 76. This study's 75 months is above that.
Counting every sponsor, half of 358 studies reached it within 50 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Eflornithine
Vanderbilt-Ingram Cancer Center →