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Urinary Biomarker Study With Sulindac and Difluoromethylornithine

Information source: Cancer Prevention Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms

Intervention: difluoromethylornithine (Drug); Sulindac (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Cancer Prevention Pharmaceuticals, Inc.


The purpose of this study is to determine the effects of 2 drugs (sulindac and Difluoromethylornithine (DFMO)) either alone or in combination on biomarkers found in urine.

Clinical Details

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

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

Primary outcome:

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

Determine dcSAM content of urine after 14 days of 500mg DFMO daily alone

Determine N1-monoacetylspermidine content of urine after 14 days plus 1 day of 150 mg sulindac alone

Determine dcSAM and N1-monoacetylspermidine content of urine after 14 days of 150 mg sulindac daily combined with DFMO at 500 mg/day

Determine dcSAM content of urine after 14 days of 500mg DFMO daily alone

Determine N1-monoacetylspermidine content of urine after 14 days plus 1 day of 150 mg sulindac alone

Secondary outcome:

Determine if 2 weeks is sufficient time for dcSAM levels and N1-monoacetylspermidine content of urine to recover after stopping DFMO and sulindac

Determine the length of time it takes for sulindac or DFMO to induce measurable changes in biomarker content of urine

Explore the effect of dietary intake of polyamine measured using the Arizona Food Frequency Questionnaire


Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Both.


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 study.

- Pregnant or lactating women

- Prior DFMO exposure

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

intolerance attributed to NSAIDs

Locations and Contacts

Additional Information

Starting date: March 2014
Last updated: July 28, 2014

Page last updated: August 23, 2015

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