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

December 12, 2012 updated by: Soligenix

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BDP 3 mg
1 mg TID
Drug: SGX201 (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.
Other Names:
  • beclomethasone 17,21-dipropionate
  • 17,-21 BDP
Experimental: BDP 6 mg
2 mg TID
Drug: SGX201 (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.
Other Names:
  • beclomethasone 17,21-dipropionate
  • 17,-21 BDP
Experimental: BDP 9 mg
3 mg TID
Drug: SGX201 (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.
Other Names:
  • beclomethasone 17,21-dipropionate
  • 17,-21 BDP
Experimental: BDP 12 mg
4 mg TID
Drug: SGX201 (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.
Other Names:
  • beclomethasone 17,21-dipropionate
  • 17,-21 BDP

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soligenix

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kevin Horgan, MD, Soligenix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 12, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Enteritis

Clinical Trials on SGX201 (delayed release beclomethasone 17,21-dipropionate)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe