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 in Patients With Rectal Cancer Treated With Combined Chemotherapy and Radiation Therapy
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Preliminary Efficacy
One day prior to and 7 days after radiation therapy
Yes
Kevin Horgan, MD
Principal Investigator
Soligenix
United States: Food and Drug Administration
BDP-ENT-01
NCT01073384
December 2009
November 2012
Name | Location |
---|---|
Northwestern University Medical Center | Chicago, Illinois 60611 |
Boston University | Boston, Massachusetts 02118 |