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A Phase 2 Urinary Biomarker Study of Polyamine Inhibition With Sulindac and Difluoromethylornithine (DFMO)

Phase 2
40 Years
65 Years
Not Enrolling
Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms

Thank you

Trial Information

A Phase 2 Urinary Biomarker Study of Polyamine Inhibition With Sulindac and Difluoromethylornithine (DFMO)

Inclusion Criteria:

- Age 40-65 years

- Fluent in English


- Must be able to discontinue the use of aspirin, aspirin containing products, and
other non-steroidal anti-inflammatory agents for the duration of the study agent
administration period

- Negative fecal occult blood test

- Hemoglobin > 10g/dl, WBC must be >4,000 mm3, platelets must be > 100,000/mm3

- Serum creatinine must be < 1.5 m/dl

- Serum bilirubin must be < 2.0 mg/dl, AST and ALT must be < 1.5x upper limit of
normal range

- Female participants must be postmenopausal (at least 1 year since the last menstrual
period), surgically sterilized, or willing to use an effective birth control method
(e.g., hormonal contraceptive, oral contraceptives, intrauterine device, diaphragm
with spermicide, or abstinence) for the duration of the study. Male subjects must use
an effective method of birth control throughout the duration of the study and should
not impregnate a female.

- Females of childbearing potential must have a negative serum pregnancy test prior to
the start of study medication.

- Able to give signed, written informed consent

Exclusion Criteria:

- Requires corticosteroids or nonsteroidal anti-inflammatory agents

- Individuals who are immunosuppressed by virtue of medication or disease. This
includes participants known to have AIDS, subjects taking oral steroids, and subjects
on immunosuppressants/immunomodulators (cyclosporine, chemotherapeutic agents, or
biologic therapy)

- Current use of phenytoin or sulfonamides

- Current or recent (within 3 months) use of coumadin or other systemic anticoagulants.

- Frequently, chronic or moderate/severe gastric complaints. Upper gastrointestinal
problems requiring prescription or nonprescription medical remedies for symptoms of
heartburn, dyspepsia, nausea, or abdominal pain > once per week on average

- History of peptic ulcer, occult or gross intestinal bleeding

- Known intercurrent illness, including but no limited to, inflammatory bowel disease,
Crohn's disease, ulcerative colitis, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, renal disease, liver disease, ongoing or active
infection, psychiatric illness, or other situations that would limit compliance or
interfere with the ability to comply with the study regimen.

- History of bleeding or clotting disorders

- Individuals with seizures or history of seizures

- History of abnormal wound healing or repair, or conditions that predisposes to the
same including diabetes

- Unwilling or unable to limit alcohol consumption to 2-3 servings per week during the
study period (12oz beer, 1 oz per alcoholic beverage, 6 oz per wine)

- Individuals enrolled in or who plan to enroll in a clinical intervention trial. There
must be a 30 day period between completing a previous study and enrolling in this

- Pregnant or lactating women

- Prior DFMO exposure

- History of allergic reaction (e.g., urticaria, asthma, rhinitis) or gastric
intolerance attributed to NSAIDs

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Measure intra-subject urine N1-monoacetylspermidine and dcSAM variability during the pre-drug phase

Outcome Description:

Measure initial variability in levels of urinary biomarkers prior to initiation of drug treatment. Three blood draws over the first 14 days will be used to assess baseline variability.

Outcome Time Frame:

Week 1-Week 2

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2013

Completion Date:

October 2015

Related Keywords:

  • Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms
  • Urinary
  • biomarkers
  • DFMO
  • sulindac
  • Neoplasms