NCT00331786已完成1 期
Phase I Multiple-Dose Safety, Pharmacokinetic and Pharmacodynamic Clinical Study of Nitric Oxide Releasing Aspirin (NCX 4016)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Effects of nitric oxide-releasing acetylsalicyclic acid (NCX 4016) on aberrant cryptic foci (ACF) multiplicity after the second dose at 6 months
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of nitric oxide-releasing acetylsalicyclic acid may prevent colorectal cancer.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of nitric oxide-releasing acetylsalicyclic acid in preventing colorectal cancer in patients at high risk of colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the effects of nitric oxide-releasing acetylsalicyclic acid on aberrant cryptic foci (ACF) in patients at high risk for colon cancer.
Secondary
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine the presence or absence of ACF in these patients.
- Determine the expression of PGE2, COX-1, COX-2, NF-kB, and β-catenin in colon tissue.
- Determine the safety and tolerability of long-term nitric oxide-releasing acetylsalicyclic acid in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •At risk for colorectal cancer
- •History of histologically proven sporadic colon adenomas or colon cancer
- •At least 5 aberrant cryptic foci on sigmoidoscopy
- •Less than 20 prior cumulative adenomas and no heredity nonpolyposis colorectal cancer
- •No significant asymptomatic lesions on sigmoidoscopy, including any of the following:
- •Inflammation
- •Strictures
- •Anorectal lesions
- •Vascular lesions
- •No adenomas or colon carcinomas on flexible sigmoidoscopy
- •No history of gastrointestinal (GI) cancer other than colorectal cancer
- •No inherited colorectal cancer syndromes
- •PATIENT CHARACTERISTICS:
- •No other GI mucosal epithelial diseases (e.g., Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue, or other disorders of nutrient absorption)
- •No active peptic ulcer disease
- •No history of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- •No known or suspected alcohol ( > 5 glasses of wine or beer per day), drug, or medication abuse
- •No quantitative or qualitative platelet or coagulation abnormalities
- •No personal or family history of a bleeding disorder
- •No uncontrolled diabetes
- •No uncontrolled hypertension, or chronic congestive heart failure (New York Heart Association class II-IV heart disease)
- •No myocardial infarction, transient ischemic attack, or stroke within the past 6 months
- •No equilibrium disorders affecting gait or ability to stand that would preclude study participation
- •No involuntary change in weight (up or down) of ≥ 15% of usual body weight within the past year
- •Creatinine ≤ 2.0 mg/dL
- •No chronic liver disease or pancreatitis
- •No allergies to aspirin
- •No prior severe adverse reactions to NSAIDs such as asthma, GI bleeding, or renal insufficiency
- •No institutionalized, mentally disabled patients
- •No prisoners
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •No concurrent antibiotic prophylaxis
- •More than 7 days since prior nonsteroidal anti-inflammatory drug (NSAID) treatment, including aspirin
- •No concurrent frequent use (> 7 days in previous month) of NSAIDs, cyclooxygenase (COX)-2 inhibitors, nitrovasodilators, or oral corticosteroids
- •No concurrent macronutrient consumption below the 1st or above the 99th percentile of U.S. consumption
- •No concurrent anticoagulants, ticlopidine, and clopidogrel
- •More than 3 months since prior general anesthesia
- •More than 3 months since prior investigational agents
- •No concurrent NSAIDs, including aspirin or COX-2 inhibitors
- •Acetaminophen allowed
- •No concurrent nitrovasodilating drugs
- •More than 3 months since prior participation in other investigational trials
排除标准
- 未提供
结局指标
主要结局
Effects of nitric oxide-releasing acetylsalicyclic acid (NCX 4016) on aberrant cryptic foci (ACF) multiplicity after the second dose at 6 months
次要结局
- Pharmacokinetic profile by blood, urine, and colon tissue sampling
- Incidence of ACF as measured by magnification chromoendoscopy
- Assessment of biomarkers expressed in colon tissue, including PGE2 (measured by immunoassay), COX-1, COX-2, NF-kB, and β-catenin (measured by immunohistochemistry) at baseline and at the final visit
- Data on C-Reactive protein as a marker for inflammation
- Safety and tolerability of long-term oral administration of NCX 4016 as measured by NCI CTCAE v3.0
研究者
研究点 (1)
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