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Sirolimus and Familial Adenomatous Polyposis (FAP)

NCT03095703 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-10-24

Study results available
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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.

Conditions

  • Adenomatous Polyposis Coli

Interventions

DRUG

Sirolimus

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.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Evelien Dekker, MD, PhD · Academic Medical Centre Amsterdam

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2018-12-10
Completion
2018-12-10

Countries

  • Netherlands

Study Locations

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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 NCT03095703 on ClinicalTrials.gov