NL-OMON47156
Completed
Phase 2
Sirolimus for the treatment of severe intestinal polyposis in patients with familial adenomatous polyposis (FAP); a pilot study - Sirolimus and FAP
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 5
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •\- \>\= 18 years
- •\-A genetically confirmed APC mutation
- •\-Classical FAP phenotype (100\-1000 colorectal adenomatous polyps)
- •\-Subtotal colectomy with ileorectal anastomosis (IRA) or ileo\-anal pouch anastomosis
- •\-Severe rectal or pouch polyposis, defined as having \>25 polyps amenable to complete removal (InSiGHT 2011 Staging System score of 3\)
- •\-Fertile patients must use effective contraception during study treatment and until 12 weeks after treatment
Exclusion Criteria
- •\-Inability to give informed consent
- •\-Participation in another interventional clinical trial
- •\-Subjects who are pregnant or breast\-feeding
- •\-Prior pelvic irradiation
- •\-Invasive malignancy in the past 5 years
- •\-Subjects who are HIV positive
- •\-Subjects with severe systemic infections, current or within 2 weeks prior to study start
- •\-Subjects with known severe restrictive or obstructive pulmonary disorders
- •\-History of pulmonary embolism or deep venous thrombosis
- •\-Major surgery less than or equal to 2 weeks prior to enrollment or any planned surgery within treatment period
Investigators
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