NCT06308445Not yet recruitingPhase 2
Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis
Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis.
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 22 Feb 2024
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2030
- Lead sponsor
- University Hospital, Toulouse
- NCT number
- NCT06308445
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 1 Sept 2026 to the primary completion date, 30 Sept 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Advanced disease with high-grade dysplasia adenoma or even adenocarcinoma in situ that should required colectomy
- Signs of primary tuberculosis infection or respiratory infection
- Any other medical or psychological condition deemed incompatible with the proper conduct of the study according to the investigator.
Other
- Inability to understand the nature and goals of the study and/or communication difficulties observed by the investigator.
- Contraindication to performing a colonoscopy.
- \< 5 polyps (\>2 mm) registered during initial colonoscopy (V1).
- Contraindications to rapamycin use
- Participation in other biomedical research
- Deprivation of liberty of the legal guardians by judicial or administrative decision.
- Pregnancy, breastfeeding
Who the study is looking for
- Children aged 12 to 17 at time of inclusion.
- Patients with colonoscopy for diagnosis or follow-up of FAP.
- ≥ 5 polyps (\> 2 mm) at initial colonoscopy (V1).
- Free and informed consent, signed by both holders of parental authority/legal representative, with the accord of the minor patient.
- Affiliated with a social security scheme.
- Patients of childbearing potential must agree to the use of a method of contraception during the study.
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Bordeaux - Hopital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Chu Montpellier Hopital Arnaud de Villeneuve Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| APHP Hôpital Robert Debré Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Toulouse Hôpital des Enfants Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.