drugset / Trial / NCT02397083

Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer

NCT02397083 ↗

Phase 2 Active not recruiting 102 enrolled M.D. Anderson Cancer Center National Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The levonorgestrel-releasing intrauterine system is designed to prevent pregnancy by releasing a hormone called levonorgestrel, which is a type of progesterone. Progesterone is a common type of hormone that is used to prevent pregnancy and may prevent or slow tumor cell growth. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether the levonorgestrel-releasing intrauterine system works better with or without everolimus in treating patients with atypical hyperplasia or stage IA grade 1 endometrial cancer.

Timeline

Start
2015-09-23
Primary completion
2026-09-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule — Oral