A Phase II/III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 7
- 主要终点
- Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses.
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent actinic keratoses.
PURPOSE: Randomized phase II/III trial to determine the effectiveness of celecoxib in preventing skin cancer in patients who have actinic keratoses.
详细描述
OBJECTIVES:
- Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses.
- Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients.
- Determine the safety of this drug in these patients.
- Compare the effect of these treatment regimens on potential surrogate end-point biomarkers in areas of actinic keratosis, sun-exposed skin, and non-sun-exposed skin and correlate these biomarkers with clinical outcome in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily for 9 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo as in arm I. Patients are followed at 2 months after completing treatment.
PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study.
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1 active arm
receipt of active drug
干预措施: celecoxib (Drug)
Group 2 active arm
receipt of active drug
干预措施: celecoxib (Drug)
group 2 placebo arm
receipt of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses.
时间窗: baseline to 2 months after last dose
次要结局
- Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients.(baseline to 2 months after last dose)
- Compare the effect of these treatment regimens on potential surrogate end-point biomarkers in areas of actinic keratosis, sun-exposed skin, and non-sun-exposed skin and correlate these biomarkers with clinical outcome in these patients.(baseline to 2 months after last dose)