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

Soligenix

Status and phase: Completed; Phase 2; Phase 1

Conditions: Enteritis

Treatments: Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01073384

1R43CA141968-01 (U.S. NIH Grant/Contract)

BDP-ENT-01

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

BDP 3 mg

Experimental group

Description:

1 mg TID

Treatment:

Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)

BDP 6 mg

Experimental group

Description:

2 mg TID

Treatment:

Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)

BDP 9 mg

Experimental group

Description:

3 mg TID

Treatment:

Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)

BDP 12 mg

Experimental group

Description:

4 mg TID

Treatment:

Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)