drugset / Trial / NCT03008408

A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma

NCT03008408

Phase 2 Active not recruiting 90 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies how well everolimus and letrozole with or without ribociclib work in treating participants with endometrial cancer that has spread to other areas of the body or has come back. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs such as everolimus and letrozole have been shown to be effective at stopping tumor growth either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib, everolimus, and letrozole may work better than everolimus and letrozole in treating participants with endometrial cancer.

Timeline

Start
2017-08-18
Primary completion
2028-08-31
Completion
2028-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule Oral
Subject Letrozole Other / unclassified Oral
Subject Ribociclib Small molecule Oral