Expanded Access to 0.5 mg eRapa for Familial Adenomatous Polyposis
ConditionFamilial Adenomatous Polyposis (FAP)
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
AgeNot listed
SponsorBiodexa Pharmaceuticals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
eRapa (encapsulated rapamycin)
DrugeRapa is a proprietary oral encapsulated formulation of rapamycin (sirolimus) provided as 0.5 mg capsules. This expanded access program uses the 0.5 mg formulation specifically developed for long-term administration.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov