NCT01073384已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Soligenix
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Preliminary Efficacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary rectal cancer
- •Planned course of conventional neoadjuvant radiation therapy before surgery
- •Scheduled to receive chemotherapy
- •>/= 18 years of age
- •Negative pregnancy test
排除标准
- •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
研究组 & 干预措施
BDP 3 mg
Experimental
1 mg TID
干预措施: SGX201 (delayed release beclomethasone 17,21-dipropionate) (Drug)
BDP 6 mg
Experimental
2 mg TID
干预措施: SGX201 (delayed release beclomethasone 17,21-dipropionate) (Drug)
BDP 9 mg
Experimental
3 mg TID
干预措施: SGX201 (delayed release beclomethasone 17,21-dipropionate) (Drug)
BDP 12 mg
Experimental
4 mg TID
干预措施: SGX201 (delayed release beclomethasone 17,21-dipropionate) (Drug)
结局指标
主要结局
Preliminary Efficacy
时间窗: One day prior to and 7 days after radiation therapy
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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