A Double-Blind, Randomized, Phase III Trial of the Safety and Efficacy of CPP-1X/Sulindac Compared With CPP-1X, Sulindac as Single Agents in Patients with Familial Adenomatous Polyposis (FAP)

Cancer Prevention Pharmaceuticals, Inc.0 个研究点目标入组 150 人开始时间: 2013年9月5日最近更新: 2019年2月28日

适应症

试验速览

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•1. Subjects (male and female), ? 18 years
•2. Diagnosis of genotypic and/or phenotypic FAP or AFAP with disease involvement of the duodenum and/or colon/rectum/pouch.
•o Genotype: APC mutation
•o Classical FAP Phenotype: 100?s to 1,000?s of colorectal adenomatous polyps, usually appearing in teenage years
•3. Patients with an intact colon/rectum, except for clinical polyposis, and prophylactic surgery is being considered as a stratification site.
•4. Rectal/pouch polyposis as a stratification site as follows: At least three years since colectomy/proctocolectomy with IRA or pouch, and demonstrating polyposis as defined by Stage 1,2,3 of proposed InSiGHT staging system.
•5. Duodenal polyposis as a stratification site; one or more of the following: Current Spigelman Stage 3 or 4. Prior surgical endoscopic intervention within the past six months for Spigelman Stage 3 or 4 that may have been down staged to Spigelman 1 or 2.
•6. Absence of major cardiac risk factors.
•7. Absence of clinically significant hearing loss requiring a hearing aid.
•8. Adequate laboratory studies (hematology, chemistry, and urinalysis) at study entry.
•9. If female, neither pregnant nor lactating.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Treatment with other FAP directed drug therapy (including sulindac or celecoxib, fish oil) within 12 weeks of study enrollment.
•2. Hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, NSAIDs, or salicylates; NSAID associated symptoms of gastritis.
•3. Patients at high cardiovascular disease risk are not eligible for study participation as defined below.
•?High risk? for cardiovascular disease is defined as:
•? Clinical diabetes mellitus (Type I or II) requiring glycemic medications, or
•? Prior personal history of cardiovascular disease ? heart attack, stroke, transient ischemic attack, or symptomatic peripheral vascular disease, or two of the following:
•-taking anti-hypertensive medication
•-taking lipid lowering medication
•-current cigarette smoker
•4. Patients with significant hearing loss are not eligible for study participation as defined below.
•? Hearing loss that affects everyday life and/or for which a hearing aid is required.
•5. Colon/rectum/pouch with high grade dysplasia or cancer on biopsy.
•6. Duodenal cancer on biopsy.
•7. Intra-abdominal desmoid disease, stage III or IV.

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