Targeted Chemoprevention of Gastric Carcinogenesis in High Risk Populations

VICC GI 1527

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.

2016-09-19

2022-12-20

2024-07-01

Active (not recruiting)

Early phase I

91

Inclusion Criteria: * Patients must have a history of a premalignant lesion of the stomach, atrophic gastritis or intestinal metaplasia * Patients must have a pure tone audiometry evaluation to document air conduction within 60 days prior to randomization. * Patients must have adequate blood counts as evidenced by the following results (obtained within 60 days): * Blood counts: WBC ≥4.0 /mcL, platelets ≥100,000 /mcL and hemoglobin ≥11.0 g/dL * Kidney function: Creatinine \<1.6 x IULN (institutional upper limit of normal) * Liver function tests: Bilirubin ≤2.0 mg/dL and AST (SGOT) or ALT (SGPT) ≤2 x IULN Exclusion Criteria: * Subjects with dysplasia (indeterminate, low grade, high grade) are not eligible for participation * Patients must not have a significant medical or psychiatric condition that would preclude study completion. * Patients with hearing loss ≥30 dB in any of the tested frequencies (250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz) are not eligible. * Patients must not have known hypersensitivity to eflornithine or the excipients. * Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis. * Patients must not have a significant cardiovascular disease history, including uncontrolled blood pressure (sBP \> 150 mmHg), myocardial infarction, cerebrovascular accident, or heart failure (New York Heart Association Class III, or IV). * Patients must not have a history of gastric or esophageal cancer, gastric resection or surgery, peptic ulcer disease (within 6 months), H. pylori treatment (within 6 months), or inflammatory bowel disease. * No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for \>5 years. * Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis. * Patients must not be pregnant or nursing (due to eflornithine pregnancy class C). Women and men of reproductive potential must have agreed to use an effective contraceptive method.

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2024-04-05