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

NCT04230499 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Encapsulated Rapamycin (eRapa)

eRapa is encapsulated rapamycin. The rapamycin is encapsulated in order to deliver the rapamycin at a consistent and lower dosage. eRapa is a capsule, and is administered orally.

Sponsors & Collaborators

  • Cancer Insight, LLC

    collaborator INDUSTRY

  • Biodexa Pharmaceuticals

    collaborator INDUSTRY

  • Rapamycin Holdings Inc.

    lead INDUSTRY

Principal Investigators

  • George E Peoples, MD · Sponsor CMO

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04230499 on ClinicalTrials.gov