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

NCT01073384 — Phase 1 / Phase 2, Completed, 16 participants, Soligenix

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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

Registry	NCT01073384
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, single group, masking: none, prevention
Enrollment	16 (Actual)
Sponsor	Soligenix (Industry); collaborators: National Cancer Institute (NCI)
Conditions	Enteritis
Interventions	SGX201 (delayed release beclomethasone 17,21-dipropionate) (Drug)
Dates	start 2009-12-01, primary completion 2012-01-01, completion 2012-11-01, first posted 2010-02-23, last updated 2012-12-17
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
BDP 3 mg	Experimental	Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)	1 mg TID
BDP 6 mg	Experimental	Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)	2 mg TID
BDP 9 mg	Experimental	Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)	3 mg TID
BDP 12 mg	Experimental	Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)	4 mg TID

SGX201 (delayed release beclomethasone 17,21-dipropionate) (Drug), also known as beclomethasone 17,21-dipropionate, 17,-21 BDP: Delayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.

+Outcome measures

Primary outcomes

Preliminary Efficacy [One day prior to and 7 days after radiation therapy]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (2)

Facility	City	Country	Status
Northwestern University Medical Center	Chicago, Illinois	United States
Boston University	Boston, Massachusetts	United States

+Investigators

Kevin Horgan, MD, Principal investigator, Soligenix

+Funding

NIH grants: R43CA141968