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NOT YET RECRUITING
NCT06308445
PHASE2

Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

Summary

The hypothesize of this research is that rapamycin is effective and well-tolerated in teenagers with familial adenomatous polyposis (FAP). Rapamycin could be effective in blocking the formation of adenomas and/or their evolution by decreasing their size and number. Researchers aim to assess the safety profile of rapamycin in FAP adolescents using a 2 low dose regimen.

Official title: Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis.

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-08-01

Completion Date

2030-08

Last Updated

2025-01-31

Healthy Volunteers

No

Interventions

DRUG

Rapamycin

This is a 2-dose rapamycin safety study, with a target through level of 3 to \<5 ng/ml for the first 3 months and 5-8 ng/ml for the next 3 months for each of the included patients. To avoid the possible cumulative effect, the two treatment phases will be separated by a 3-weeks wash-out period.

Locations (4)

CHU Bordeaux Hôpital Pellegrin

Bordeaux, France

CHU Montpellier Hôpital Arnaud de Villeneuve

Montpellier, France

APHP Hôpital Robert Debré

Paris, France

CHU Toulouse Hôpital des Enfants

Toulouse, France