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
18 Years
N/A
Not Enrolling
Both
Enteritis
Both
Enteritis
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 Center | Chicago, Illinois 60611 |
| Boston University | Boston, Massachusetts 02118 |
