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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Soligenix
ClinicalTrials.gov Identifier:
NCT01073384
First received: February 19, 2010
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Enteritis
Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Soligenix:

Primary Outcome Measures:
  • Preliminary Efficacy [ Time Frame: One day prior to and 7 days after radiation therapy ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: December 2009
Study Completion Date: November 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073384

Locations
United States, Illinois
Northwestern University Medical Center
Chicago, Illinois, United States
United States, Massachusetts
Boston University
Boston, Massachusetts, United States
Sponsors and Collaborators
Soligenix
Investigators
Principal Investigator: Kevin Horgan, MD Soligenix
  More Information

Additional Information:
No publications provided

Responsible Party: Soligenix
ClinicalTrials.gov Identifier: NCT01073384     History of Changes
Other Study ID Numbers: BDP-ENT-01, 1R43CA141968-01
Study First Received: February 19, 2010
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rectal Neoplasms
Enteritis
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Gastroenteritis
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 27, 2014