Trial of ERapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance

Phase 2 Active not recruiting 30 enrolled Rapamycin Holdings Inc. Biodexa Pharmaceuticals · collab Cancer Insight, LLC · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

Patients with Familial Adenomatous Polyposis (FAP) who are undergoing endoscopic surveillance will be given Encapsulated Rapamycin (eRapa) at one of three escalating doses/schedules for 12 months with the aim of reducing polyp burden.

Timeline

Start: 2021-01-18
Primary completion: 2025-03
Completion: 2025-03

Outcome

Met primary endpoint

release “eRapa appeared safe and well-tolerated with a significant 24% reduction in the total polyp burden at six months compared with baseline (p=0.04)” biodexapharma.com ↗

Publications

Stone JK, Mehta NA, Singh H, El-Matary W, Bernstein CN. Endoscopic and chemopreventive management of familial adenomatous polyposis syndrome. Fam Cancer. 2023 Oct;22(4):413-422. doi: 10.1007/s10689-023-00334-3. Epub 2023 Apr 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rapamycin	Small molecule	0.5 mg	Oral