drugset / Trial / NCT00811590

Pilot Study of mTOR Inhibitor Therapy in Peutz-Jeghers Syndrome

NCT00811590 ↗

Phase 2 Terminated 3 enrolled University of Utah Novartis · collab
NaSingle-groupOpen-labelTreatment

Summary

Pilot study, Open-label, Phase II study of Everolimus. Objective: To determine if Everolimus can diminish large gastrointestinal polyps in patients with Peutz-Jeghers Syndrome. Methodology: Polyp size and number will be compared to baseline by FDG-PET and CT and 12 months after treatment with Everolimus. Since this is a pilot study, the polyps prior to treatment will serve as the controls.

Timeline

Start
2008-11
Primary completion
2011-03
Completion
2011-03

Outcome

Outcome not reported

Stopped (Enrollment): “The study was ended early due to low enrollment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule — —