NL-OMON44874已完成3 期
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) - CPP FAP-310
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects (male and female), * 18 years
- •1. Diagnosis of phenotypic classical FAP with disease involvement of the duodenum and/or colon/rectum/pouch.
- •a. Genotype: APC mutation (with or without family history) required
- •b. Classical FAP Phenotype: 100*s to 1,000*s of colorectal adenomatous polyps, usually appearing in teenage years
- •2. UGI endoscopy/LGI endoscopy (proctoscopy/colonoscopy) performed within 30 days of randomization.
- •3. Patients with an intact colon/rectum and prophylactic surgery is being considered as a stratification site.
- •4. Rectal/pouch polyposis as a stratification site as follows:
- •4.a At least three years since colectomy with IRA/proctocolectomy with pouch, and demonstrating polyposis as defined by Stage 1, 2, 3, of the proposed InSiGHT 2011 Staging System (protocol Appendix B) and summarized as follows:
- •Stage 1: 10-25 polyps, all < 5 mm
- •Stage 2: 10-25 polyps, at least one > 1 cm
- •Stage 3: >25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any prior evidence of high grade dysplasia, even if completely removed. [Note: For staging purposes only.]
- •4.b For all subjects, any rectal/pouch polyps > 5 mm must be excised at *baseline*.
- •5. Duodenal polyposis as a stratification site; one or more of the following:
- •5.a Current Spigelman Stage 3 or 4. (Refer to protocol Appendix A for Modified Spigelman Score and Classification table).
- •5.b 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. Hematopoietic Status (within 30 days prior to randomization):
- •a) No significant hematologic abnormalities
- •b) WBC at least 3000/mm3
- •c) Platelet count at least 100,000/mm3
- •d) Hemoglobin at least 10.0 g/dL
- •e) No history of clinical coagulopathy
- •7. Hepatic Status (within 30 days prior to randomization):
- •a) Bilirubin no greater than 1.5 times ULN
- •b) AST and ALT no greater than 1.5 times ULN
- •c) Alkaline phosphatase no greater than 1.5 times ULN
- •8. Renal Status (within 30 days prior to randomization):
- •a) Creatinine no greater than 1.5 times ULN
- •9. Hearing:
- •a) No clinically significant hearing loss, defined in Section 6.2, number 9.
- •10. If female, neither pregnant nor lactating.
- •11. Negative pregnancy test if female of child-bearing potential. Fertile patients must use effective contraception. Confirmation of postmenopausal status unless surgically sterile.
- •12. Absence of gross blood in stool; red blood on toilet paper only acceptable.
- •13. No discrete gastric or duodenal ulcer greater than 5 mm within the past year except Helicobacter pylori-related peptic ulcer disease treated with antibiotics.
- •14. No invasive malignancy within the past 5 years except resected non-melanomatous skin cancer, papillary thyroid cancer, or precancerous cervical dysplasia.
- •15. No other significant medical or psychiatric problems that would preclude study participation or interfere with capacity to give informed consent.
- •16. Use of 81 to 100 mg daily aspirin or up to 700 mg aspirin not more than once a week are eligible.
- •17. No concurrent warfarin, fluconazole, lithium, Pradaxa® or other direct thrombin inhibitors, Plavix®, cyclosporine, other NSAIDs (such as ibuprofen, aspirin, diflunisal), diuretics (furosemide and thiazides), DMSO, methotrexate, probenecid, propoxyphene hydrochloride, Tylenol® (acetami
排除标准
- •1. Prior pelvic irradiation.
- •2. Patients receiving oral corticosteroids within 30 days of enrollment.
- •3. Treatment with other investigational agents in the prior 4 weeks.
- •4. Use of other non-steroidal anti-inflammatory drugs (such as ibuprofen) exceeding 4 days per month, in the prior 6 weeks.
- •5. Regular use of aspirin in excess of 700 mg per week.
- •6. Treatment with other FAP directed drug therapy (including sulindac or celecoxib, fish oil) within 12 weeks of study enrollment.
- •7. Hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, NSAIDs, or salicylates; NSAID associated symptoms of gastritis.
- •8. Patients must not have cardiovascular disease risk factors as defined below.
- •* Uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg;
- •* Unstable angina;
- •* History of documented myocardial infarction or cerebrovascular accident;
- •* New York Heart Association Class III or IV heart failure (Refer to Appendix C);
- •* Known uncontrolled hyperlipidemia defined as LDL-C * 190 mg/dL or triglycerides * 500 mg/dL.
- •9. 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.
- •10. Colon/rectum/pouch with high grade dysplasia or cancer on biopsy or a large polyp (>1 cm) not amenable to complete removal.
- •11. Duodenal cancer on biopsy.
- •12. Intra-abdominal desmoid disease, stage III or IV (staging criteria in protocol Appendix D).
- •13. Inability to provide informed consent.
研究者
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