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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Enteritis

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Preliminary Efficacy

Outcome Time Frame:

One day prior to and 7 days after radiation therapy

Safety Issue:

Yes

Principal Investigator

Kevin Horgan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Soligenix

Authority:

United States: Food and Drug Administration

Study ID:

BDP-ENT-01

NCT ID:

NCT01073384

Start Date:

December 2009

Completion Date:

November 2012

Related Keywords:

  • Enteritis
  • Rectal Neoplasms
  • Enteritis

Name

Location

Northwestern University Medical CenterChicago, Illinois  60611
Boston UniversityBoston, Massachusetts  02118