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Completed

NCT Number: NCT01073384

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

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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Key information

Conditions

Enteritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Northwestern University Medical Center, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SGX201 (delayed release beclomethasone 17,21-dipropionate)

Drug

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

Primary outcomes

  1. Preliminary Efficacy

    Time frame: One day prior to and 7 days after radiation therapy

Sponsors and collaborators

Lead sponsor

Soligenix

Industry

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 23, 2010
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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