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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.
Details
| Lead sponsor | Cancer Prevention Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2014-03 |
| Completion | 2016-04 |
Conditions
- Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms
Interventions
- difluoromethylornithine
- Sulindac
Primary outcomes
- Measure intra-subject urine N1-monoacetylspermidine and dcSAM variability during the pre-drug phase — 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 — 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 — 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 — Week 20
- Determine dcSAM content of urine after 14 days of 500mg DFMO daily alone — 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 — 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).