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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01073384

Enrollment

Registered

2010-02-23

Start date

2009-12-31

Completion date

2012-11-30

Last updated

2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteritis

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.

Interventions

DRUGSGX201 (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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Preliminary Efficacy	One day prior to and 7 days after radiation therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026