Sirolimus and Familial Adenomatous Polyposis (FAP)

PHASE2CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

October 3, 2017

Primary Completion Date

December 10, 2018

Study Completion Date

December 10, 2018

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.

Trial Locations (1)

1105AZ

Academic Medical Centre, Amsterdam

All Listed Sponsors
lead

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

OTHER

NCT03095703 - Sirolimus and Familial Adenomatous Polyposis (FAP) | Biotech Hunter | Biotech Hunter