Expanded Access to 0.5 mg eRapa for Familial Adenomatous Polyposis (NCT07689942) | Clinical Trial Compass
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Expanded Access to 0.5 mg eRapa for Familial Adenomatous Polyposis
Plain-language summary
This expanded access program provides 0.5 mg eRapa (encapsulated rapamycin) to patients with familial adenomatous polyposis (FAP) who have no satisfactory alternative treatment options and are not eligible to participate in a clinical trial. The objective is to provide access to eRapa based on the treating physician's assessment that the potential benefits outweigh the potential risks, with appropriate clinical monitoring for safety and tolerability.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient is post pubertal and reached full adult height
. Patient has FAP confirmed by APC genotype mutation tesing or a history of FAP in one of the parents. Genetic mosaics or Attenuated (as well as classical) FAP may participate
. Patient has significant colorectal and/or duodenal FAP disease burden.
Exclusion criteria
. Patient has existing carcinoma or high-grade dysplasia in the GI tract and/or requires imminent definitive surgical intervention (either partial or complete colectomy or duodenectomy).
. Patient with an acquired or congenital immunodeficiency, active and clinically significant tuberculosis, bacterial, fungal, or viral infections, including HIV.
. Patient has clinically significant elevations of hepatic enzymes or bilirubin, or other evidence of active hepatitis.
. Patient has clinically significant impairment of renal function.
. Patient has a history or evidence of clinically significant hyperlipoproteinemia or hypertriglyceridemia.
. Patient has active or recurrent bouts of pancreatitis, or clinically significant elevations of lipase or amylase.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patient is taking medications that are considered strong inducers or inhibitors of cytochrome P450 (CYP) 3A4/5 or strong inducers or inhibitors of P-glycoprotein 1 (P-gp1) that cannot be discontinued at least 1 week prior to first dose of treatment intervention and for the duration of the treatment.
. Patients with known hypersensitivity to rapamycin (sirolimus) or any of the excipients in eRapa.