A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer
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
2 other identifiers
interventional
16
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2009
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 19, 2010
CompletedFirst Posted
Study publicly available on registry
February 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedDecember 17, 2012
December 1, 2012
2.1 years
February 19, 2010
December 12, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Preliminary Efficacy
One day prior to and 7 days after radiation therapy
Study Arms (4)
BDP 3 mg
EXPERIMENTAL1 mg TID
BDP 6 mg
EXPERIMENTAL2 mg TID
BDP 9 mg
EXPERIMENTAL3 mg TID
BDP 12 mg
EXPERIMENTAL4 mg TID
Interventions
Delayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.
Eligibility Criteria
You may qualify if:
- Primary rectal cancer
- Planned course of conventional neoadjuvant radiation therapy before surgery
- Scheduled to receive chemotherapy
- \>/= 18 years of age
- Negative pregnancy test
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Soligenixlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Northwestern University Medical Center
Chicago, Illinois, United States
Boston University
Boston, Massachusetts, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Horgan, MD
Soligenix
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2010
First Posted
February 23, 2010
Study Start
December 1, 2009
Primary Completion
January 1, 2012
Study Completion
November 1, 2012
Last Updated
December 17, 2012
Record last verified: 2012-12