At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 5 enrolled
Drug / intervention
Sirolimusdrug
Likely dose
Sirolimus 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Sirolimus for Cowden Syndrome With Colon Polyposis
In Brief
A Phase 2 clinical trial evaluating Sirolimus for PTEN Gene Mutation and 6 related conditions. Completed, enrolled 5 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTEN Gene Mutation, PTEN Hamartoma Tumor Syndrome, PTEN Hamartoma Syndrome, Cowden Syndrome, Bannayan Syndrome, Bannayan Zonana Syndrome, Polyposis
CountriesUnited States
CollaboratorsPTEN Research, Pfizer
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartSep 2019
First PostedSep 2019
Primary CompletionFeb 2025
Study CompletionJun 2025
TodayJul 2026
First PostedSep 19, 2019
Enrollment StartSep 16, 2019
Primary CompletionFeb 1, 2025
Study CompletionJun 5, 2025
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 6.8 years ago
Interventions
Sirolimusdrug
Use of sirolimus 2 mg by mouth daily for 1 year