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

Primary Purpose

Enteritis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGX201 (delayed release beclomethasone 17,21-dipropionate)
Sponsored by
Soligenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Enteritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Northwestern University Medical Center
  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

BDP 3 mg

BDP 6 mg

BDP 9 mg

BDP 12 mg

Arm Description

1 mg TID

2 mg TID

3 mg TID

4 mg TID

Outcomes

Primary Outcome Measures

Preliminary Efficacy

Secondary Outcome Measures

Full Information

First Posted
February 19, 2010
Last Updated
December 12, 2012
Sponsor
Soligenix
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01073384
Brief Title
A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soligenix
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BDP 3 mg
Arm Type
Experimental
Arm Description
1 mg TID
Arm Title
BDP 6 mg
Arm Type
Experimental
Arm Description
2 mg TID
Arm Title
BDP 9 mg
Arm Type
Experimental
Arm Description
3 mg TID
Arm Title
BDP 12 mg
Arm Type
Experimental
Arm Description
4 mg TID
Intervention Type
Drug
Intervention Name(s)
SGX201 (delayed release beclomethasone 17,21-dipropionate)
Other Intervention Name(s)
beclomethasone 17,21-dipropionate, 17,-21 BDP
Intervention Description
Delayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.
Primary Outcome Measure Information:
Title
Preliminary Efficacy
Time Frame
One day prior to and 7 days after radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Horgan, MD
Organizational Affiliation
Soligenix
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.soligenix.com
Description
Sponsor

Learn more about this trial

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

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