Trials / Completed
CompletedNCT01073384
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Soligenix · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2012-01-01
- Completion
- 2012-11-01
- First posted
- 2010-02-23
- Last updated
- 2012-12-17
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01073384. Inclusion in this directory is not an endorsement.