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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

January 31, 2012

Study Completion Date

November 30, 2012

Conditions
Enteritis
Interventions
DRUG

SGX201 (delayed release beclomethasone 17,21-dipropionate)

Delayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.

Trial Locations (2)

Unknown

Northwestern University Medical Center, Chicago

Boston University, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Soligenix

INDUSTRY