Treatment of Familial Adenomatous Polyposis (FAP) with CPP-1X (eflornithine) plus sulindac

Phase 1

• Conditions: Familial Adenomatous Polyposis (FAP); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-000427-41-GB
• Lead Sponsor: Cancer Prevention Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-11
• Study Completion: 2018-11-25
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

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 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 172
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior pelvic irradiation
2. Patients receiving oral corticosteroids within 30 days of enrolment
3. Treatment with other investigational agents within the prior 4 weeks
4. Use of other non-steroidal anti-inflammatory drugs (such as ibuprofen) exceeding 4 days per month, in the prior 6weeks
5. Regular use of aspirin in excess of 700mg 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 at high cardiovascular disease risk are not eligible for study participation 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;
•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. Intact colon/rectum or retained rectum or ileal pouch:
a) cancer on biopsy
b)high grade dysplasia found on polyp biopsy where the polyp is not completely removed
c)a large polyp (>1cm) not completely removed
11. Duodenal cancer on biopsy.
12. Intra-abdominal desmoid disease, stage III or IV.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified