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Sirolimus for Cowden Syndrome With Colon Polyposis

NCT04094675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-06-10

No results posted yet for this study

Summary

Colon polyposis (the presence of multiple colon polyps) is very common with Cowden syndrome, as over 60% of patients have 50 or more polyps. In a previous clinical trial, some participants had reduction in the number of colon polyps with the use of the medication sirolimus for a very short time period. This study is investigating sirolimus and its effect on the number of colon polyps in patients with Cowden syndrome and polyposis over a 1 year period.

Conditions

  • PTEN Gene Mutation
  • PTEN Hamartoma Tumor Syndrome
  • PTEN Hamartoma Syndrome
  • Cowden Syndrome
  • Bannayan Syndrome
  • Bannayan Zonana Syndrome
  • Polyposis

Interventions

DRUG

Sirolimus

Use of sirolimus 2 mg by mouth daily for 1 year

Sponsors & Collaborators

  • PTEN Research

    collaborator UNKNOWN

  • Pfizer

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Peter P Stanich, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2025-02-01
Completion
2025-06-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04094675 on ClinicalTrials.gov