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

Enteritis Clinical Trial

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 in Patients With Rectal Cancer Treated With Combined Chemotherapy and Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073384
• Other study ID #: BDP-ENT-01
• Secondary ID: 1R43CA141968-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 19, 2010
• Last updated: December 12, 2012
• Start date: December 2009
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Soligenix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Enteritis

Intervention

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.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts
United States	Northwestern University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Soligenix	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary Efficacy		One day prior to and 7 days after radiation therapy	Yes

External Links

•   Sponsor