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

Phase 1

Completed

• Conditions: Enteritis
• Interventions: Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)

• Registration Number: NCT01073384
• Lead Sponsor: Soligenix

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 Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Primary Completion: 2012-01
• Study Completion: 2012-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-12
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Primary rectal cancer
• Planned course of conventional neoadjuvant radiation therapy before surgery
• Scheduled to receive chemotherapy
• >/= 18 years of age
• Negative pregnancy test

Exclusion Criteria

• History of acute or chronic regional enteritis or inflammatory bowel disease
• Stool incontinence
• Uncontrollable diarrhea
• Abdominal-perineal resection or other surgery leaving patient without a functioning rectum
• Patients using colostomy or ileostomy
• Liver function tests > 3x upper limit of normal, or bilirubin test result > 1.5 the upper limit of normal
• Calculated creatinine clearance <60 mL/minute
• Planned hyperfractionated or split course radiation
• Planned brachytherapy prior to completion of all external beam radiation therapy
• Prior pelvic RT
• An on-going infection
• ECOG score >/= 3
• Leukopenia <2,000 WBC/mm3 or Hg <10.5 g/dL
• Participation in an investigational drug trial within the previous 30 days
• Patients with a medical condition that would interfere with study compliance
• Known hypersensitivity to 5-FU or capecitabine
• Anticipated inability to tolerate oral administration of SGX201
• Pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BDP 3 mg	SGX201 (delayed release beclomethasone 17,21-dipropionate)	1 mg TID
BDP 6 mg	SGX201 (delayed release beclomethasone 17,21-dipropionate)	2 mg TID
BDP 9 mg	SGX201 (delayed release beclomethasone 17,21-dipropionate)	3 mg TID
BDP 12 mg	SGX201 (delayed release beclomethasone 17,21-dipropionate)	4 mg TID

Primary Outcome Measures

Name	Time	Method
Preliminary Efficacy	One day prior to and 7 days after radiation therapy

Trial Locations

Locations (2)

Northwestern University Medical Center; 🇺🇸 Chicago, Illinois, United States

Boston University; 🇺🇸 Boston, Massachusetts, United States