A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer
This study has been completed.
Sponsor:
Soligenix
Collaborator:
Information provided by (Responsible Party):
Soligenix
ClinicalTrials.gov Identifier:
NCT01073384
First received: February 19, 2010
Last updated: December 12, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Enteritis |
Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Soligenix:
Primary Outcome Measures:
- Preliminary Efficacy [ Time Frame: One day prior to and 7 days after radiation therapy ] [ Designated as safety issue: Yes ]
| Enrollment: | 16 |
| Study Start Date: | December 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BDP 3 mg
1 mg TID
|
Drug: 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 Names:
|
|
Experimental: BDP 6 mg
2 mg TID
|
Drug: 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 Names:
|
|
Experimental: BDP 9 mg
3 mg TID
|
Drug: 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 Names:
|
|
Experimental: BDP 12 mg
4 mg TID
|
Drug: 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 Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073384
Locations
| United States, Illinois | |
| Northwestern University Medical Center | |
| Chicago, Illinois, United States | |
| United States, Massachusetts | |
| Boston University | |
| Boston, Massachusetts, United States | |
Sponsors and Collaborators
Soligenix
Investigators
| Principal Investigator: | Kevin Horgan, MD | Soligenix |
More Information
Additional Information:
No publications provided
| Responsible Party: | Soligenix |
| ClinicalTrials.gov Identifier: | NCT01073384 History of Changes |
| Other Study ID Numbers: | BDP-ENT-01, 1R43CA141968-01 |
| Study First Received: | February 19, 2010 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rectal Neoplasms Enteritis Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
Gastroenteritis Beclomethasone Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 13, 2013