Clinical trial · Interventional
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
NCT01073384CI-TRIAL-00008683completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Enteritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGX201 (delayed release beclomethasone 17,21-dipropionate) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- BDP 3 mg
- description
- 1 mg TID
- interventionNames
- Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)
- type
- EXPERIMENTAL
- label
- BDP 6 mg
- description
- 2 mg TID
- interventionNames
- Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)
- type
- EXPERIMENTAL
- label
- BDP 9 mg
- description
- 3 mg TID
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.