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WithdrawnNCT01636128Updated Jul 30, 2014

Urinary Biomarker Study With Sulindac and Difluoromethylornithine

A Phase 2 interventional study of difluoromethylornithine and Sulindac in Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms, sponsored by Cancer Prevention Pharmaceuticals, Inc.. Withdrawn. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-30.

Sponsored by Cancer Prevention Pharmaceuticals, Inc. · Phase 2, Interventional, and Diagnostic

Why this study was withdrawn
Funding and staffing
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms

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Keywords

  • Urinary
  • biomarkers
  • DFMO
  • sulindac
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

Browse Neoplasms studies →

Lead sponsor

Cancer Prevention Pharmaceuticals, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Age 40-65 years
  • Fluent in English
  • PS 0 ECOG
  • 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

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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Sulindac first (Treatment Sequence B)

    Sulindac alone, washout, DFMO alone, then combination of sulindac and DFMO

    Drug: difluoromethylornithine · Drug: Sulindac

  • Experimental
    DFMO first (Treatment Sequence A)

    DFMO alone, followed by washout, sulindac alone, then combination of DFMO and sulindac

    Drug: difluoromethylornithine · Drug: Sulindac

Interventions

  • Drugdifluoromethylornithine

    500 mg oral for 14 days, combined with sulindac for 15 days

    Also known as: DFMO, eflornithine

  • DrugSulindac

    150 mg oral for 15 days, combined with DFMO for 14 days

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Week 1-Week 2

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

    Measure urinary biomarker dcSAM after 14 days of single agent DFMO. Measure urinary biomarker dcSAM after 14 days of single agent DFMO for treatment arm where DFMO alone is started week 2 (Treatment sequence A).

    Time frame: Week 4

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

    Measure urinary biomarker dcSAM after 14 days of single agent sulindac. Measure urinary biomarker dcSAM after 14 days of single agent sulindac for treatment arm where sulindac alone is started week 2 (Treatment sequence B).

    Time frame: Week 4

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

    Time frame: Week 20

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

    Measure urinary biomarker dcSAM after 14 days of single agent DFMO for treatment arm where DFMO alone is started week 10 (Treatment sequence B)

    Time frame: Week 12

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

    Measure urinary biomarker dcSAM after 14 days of single agent sulindac. Measure urinary biomarker dcSAM after 14 days of single agent sulindac for treatment arm where sulindac alone is stated week 10 (Treatment sequence A).

    Time frame: Week 12

Secondary outcomes

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

    Time frame: Week 22

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

    Time frame: Week 3-Week 25

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

    Quantitate dietary polyamine levels over the course of the study and evaluate the effects on biomarkers evaluated in the primary outcome measures.

    Time frame: Week 1-25

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01636128
Lead sponsor
Cancer Prevention Pharmaceuticals, Inc.
Collaborators
University of Arizona
Responsible party
Patricia Thompson-Carino (Associate Professor, Cellular and Molecular Medicine, University of Arizona) — Principal investigator
First posted
Jul 10, 2012
Start date
Mar 2014
Primary completion
Mar 2016 (estimated)
Completion
Apr 2016 (estimated)
Last update
Jul 30, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Eflornithine · Sulindac

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Cancer Prevention Pharmaceuticals, Inc.

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