Clinical trial · Interventional
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.
NCT06308445CI-TRIAL-00110894RAPA-4-PAFnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rapamycin | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rapamycin
- interventionNames
- Drug: Rapamycin
Primary outcomes (1)
- measure
- Evaluation of the safety profile of two doses of rapamycin in adolescents with Familial Adenomatous Polyposis.
- timeFrame
- For the entire duration of taking the experimental drug (rapamycin) and up to one month after stopping.
- description
- Monitoring of adverse events (EvI) and serious adverse events (SvIG). Particular attention will be paid to known adverse events attributable to rapamycin according to the summary of product characteristics (SmPC).
Secondary outcomes (3)
- measure
- Evaluation of the effect of rapamycin on the number of polyps, on the entire colon and by segments (rectum, left colon, transverse colon and right colon) in adolescents suffering from Familial Adenomatous Polyposis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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. * Contraindications to rapamycin use * Participation in other biomedical research * Deprivation of liberty of the legal guardians by judicial or administrative decision. * Pregnancy, breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.