NCT01636128

Urinary Biomarker Study With Sulindac and Difluoromethylornithine

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cancer Prevention Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	difluoromethylornithine	500 mg oral for 14 days, combined with sulindac for 15 days
DRUG	Sulindac	150 mg oral for 15 days, combined with DFMO for 14 days

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2012-07-10
• Last updated: 2014-07-30