Focus of Study: Drug Response Biomarkers, Chemoprevention, NeoplasmsPhase 2NCT01636128
Urinary Biomarker Study With Sulindac and Difluoromethylornithine
A Phase 2 study testing difluoromethylornithine and Sulindac in people with Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms, run by Cancer Prevention Pharmaceuticals, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms
- What is being tested?
- difluoromethylornithine and Sulindac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: A Phase 2 Urinary Biomarker Study of Polyamine Inhibition With Sulindac and Difluoromethylornithine (DFMO)
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.
- Being tested
- difluoromethylornithine, Sulindac
- Keywords
- Urinary, biomarkers, DFMO, sulindac
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
difluoromethylornithineDrug
Also called DFMO, eflornithine
500 mg oral for 14 days, combined with sulindac for 15 days
SulindacDrug
150 mg oral for 15 days, combined with DFMO for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Sulindac first (Treatment Sequence B) | Experimental | Sulindac alone, washout, DFMO alone, then combination of sulindac and DFMO Receives: Drug: difluoromethylornithine; Drug: Sulindac |
| DFMO first (Treatment Sequence A) | Experimental | DFMO alone, followed by washout, sulindac alone, then combination of DFMO and sulindac Receives: Drug: difluoromethylornithine; Drug: Sulindac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1-Week 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).
Measured: Week 4
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).
Measured: Week 4
Determine dcSAM and N1-monoacetylspermidine content of urine after 14 days of 150 mg sulindac daily combined with DFMO at 500 mg/day
Measured: Week 20
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)
Measured: Week 12
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).
Measured: Week 12
Secondary outcomes (3)
Determine if 2 weeks is sufficient time for dcSAM levels and N1-monoacetylspermidine content of urine to recover after stopping DFMO and sulindac
Measured: Week 22
Determine the length of time it takes for sulindac or DFMO to induce measurable changes in biomarker content of urine
Measured: Week 3-Week 25
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.
Measured: Week 1-25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startMar 2014
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Funding and staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: Drug Response Biomarkers, Chemoprevention, NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Prevention Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona
- Responsible party
- Principal investigator, Patricia Thompson-Carino, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636128
- Sponsor's protocol ID
- UA-UB-101
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2012
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Urinary Biomarker Study of Polyamine Inhibition With Sulindac and Difluoromethylornithine (DFMO)
- ClinicalTrials.gov ID
- NCT01636128
- Acronym / sponsor ID
- UA-UB-101
- Keywords
- Urinary, biomarkers, DFMO, sulindac
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding and staffing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cancer Prevention Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulindac first (Treatment Sequence B) | Experimental | Drug: difluoromethylornithine, Drug: SulindacSulindac alone, washout, DFMO alone, then combination of sulindac and DFMO |
| DFMO first (Treatment Sequence A) | Experimental | Drug: difluoromethylornithine, Drug: SulindacDFMO alone, followed by washout, sulindac alone, then combination of DFMO and sulindac |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| difluoromethylornithineAlso: DFMO, eflornithine500 mg oral for 14 days, combined with sulindac for 15 days | Drug | DFMO first (Treatment Sequence A), Sulindac first (Treatment Sequence B) |
| Sulindac150 mg oral for 15 days, combined with DFMO for 14 days | Drug | DFMO first (Treatment Sequence A), Sulindac first (Treatment Sequence B) |
Primary outcome
Measure intra-subject urine N1-monoacetylspermidine and dcSAM variability during the pre-drug phase
Time frame: Week 1-Week 2
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.
Determine dcSAM content of urine after 14 days of 500mg DFMO daily alone
Time frame: Week 4
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).
Determine N1-monoacetylspermidine content of urine after 14 days plus 1 day of 150 mg sulindac alone
Time frame: Week 4
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).
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
Determine dcSAM content of urine after 14 days of 500mg DFMO daily alone
Time frame: Week 12
Measure urinary biomarker dcSAM after 14 days of single agent DFMO for treatment arm where DFMO alone is started week 10 (Treatment sequence B)
Determine N1-monoacetylspermidine content of urine after 14 days plus 1 day of 150 mg sulindac alone
Time frame: Week 12
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).
3 secondary outcomes
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
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
Explore the effect of dietary intake of polyamine measured using the Arizona Food Frequency Questionnaire
Time frame: Week 1-25
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing difluoromethylornithine and Sulindac in people with Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms, run by Cancer Prevention Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure intra-subject urine N1-monoacetylspermidine and dcSAM variability during the pre-drug phase (time frame: Week 1-Week 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.