Clinical Trial: A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1/2 Study to Evaluate Escalating Doses of SGX201 [Delayed Release Oral Beclomethasone Dipropionate (BDP)] for Prevention of Signs and Symptoms of Acute Enteritis i

Brief Summary: The purpose of this study is to evaluate the safety and preliminary efficacy of four doses of SGX201 in subjects with rectal cancer treated with concurrent radiation and chemotherapy.

Detailed Summary:
Sponsor: Soligenix

Current Primary Outcome: Preliminary Efficacy [ Time Frame: One day prior to and 7 days after radiation therapy ]

Original Primary Outcome: Maximum Tolerated Dose [ Time Frame: One day prior to and 7 days after radiation therapy ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Soligenix

Dates:
Date Received: February 19, 2010
Date Started: December 2009
Date Completion:
Last Updated: December 12, 2012
Last Verified: December 2012