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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Enteritis

Intervention / Treatment
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* Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BDP 3 mg<br>1 mg TID | Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)<br>* Delayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.<br>* Other names: 17,-21 BDP;|
| Experimental: BDP 6 mg<br>2 mg TID | Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)<br>* Delayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.<br>* Other names: 17,-21 BDP;|
| Experimental: BDP 9 mg<br>3 mg TID | Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)<br>* Delayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.<br>* Other names: 17,-21 BDP;|
| Experimental: BDP 12 mg<br>4 mg TID | Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)<br>* Delayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.<br>* Other names: 17,-21 BDP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary Efficacy |  | One day prior to and 7 days after radiation therapy |