CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Sirolimusdrug
Likely dose
Sirolimus 2 mg once daily (starting dose), adjusted to maintain trough level 5-8 ng/mLAI-extracted
Key inclusion· 5
  • ✓Age ≥18 years
  • ✓Genetically confirmed APC mutation
  • ✓Classical FAP phenotype with 100-1000 colorectal adenomatous polyps
  • ✓Prior subtotal colectomy with ileorectal anastomosis (IRA) or total colectomy with ileo-anal pouch anastomosis (IPAA)
Key exclusion· 14
  • ✕Prior pelvic irradiation
  • ✕Invasive malignancy within past 5 years
  • ✕HIV positive status
  • ✕Severe systemic infections currently or within 2 weeks before study start

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03095703
NCT03095703Phase 2Completed
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Sirolimus for the Treatment of Severe Intestinal Polyposis in Patients With Familial Adenomatous Polyposis (FAP): a Pilot Study

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·interventional·Posted Mar 30, 2017·Updated Oct 24, 2024

In Brief

A Phase 2 clinical trial evaluating Sirolimus for Adenomatous Polyposis Coli. Completed, enrolled 4 participants across 1 site.

Detailed Summary

The aim of the study is to investigate the effect of sirolimus on the progression of intestinal adenomas in patients with FAP and to assess the safety of this treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenomatous Polyposis Coli
CountriesNetherlands
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 30, 2017
Enrollment StartOct 3, 2017
Primary CompletionDec 10, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.3 years ago

Interventions

Sirolimusdrug

Participants will be given sirolimus tablets. The starting dose is 2 mg once daily which will be given in 1mg tablets. On day 7 the first trough level is measured (using the LC-MS/MS method) and if not within the target range of 5-8ng/ml, dosing adjustments are made. In case of dosing adjustments, the next trough level is measured seven days later and this is repeated weekly until the target range is achieved. In case trough levels are within the target range, the next trough level measurement is at month 3, after which dosing adjustments are made if necessary, and at month 6. The maximum daily dose is 40mg. No placebo is given.