A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer
NCT ID: NCT01073384
Last Updated: 2012-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2009-12-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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BDP 3 mg
1 mg TID
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.
BDP 6 mg
2 mg TID
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.
BDP 9 mg
3 mg TID
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.
BDP 12 mg
4 mg TID
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned course of conventional neoadjuvant radiation therapy before surgery
* Scheduled to receive chemotherapy
* \>/= 18 years of age
* Negative pregnancy test
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Soligenix
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Horgan, MD
Role: PRINCIPAL_INVESTIGATOR
Soligenix
Locations
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Northwestern University Medical Center
Chicago, Illinois, United States
Boston University
Boston, Massachusetts, United States
Countries
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Related Links
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Sponsor
Other Identifiers
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BDP-ENT-01
Identifier Type: -
Identifier Source: org_study_id