CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
everolimus +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01642186
NCT01642186Phase 2Completed

A Randomized Three Arm Phase II Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC)

Memorial Sloan Kettering Cancer Center·interventional·Posted Jul 17, 2012·Updated Dec 29, 2022

In Brief

A Phase 2 clinical trial evaluating everolimus, letrozole plus leuprolide, and 1 other intervention for Fibrolamellar Carcinoma and Fibrolamellar Liver Cancer. Completed, enrolled 28 participants across 6 sites.

Detailed Summary

There is no effective standard treatment for fibrolamellar liver cancer that cannot be removed by surgery. The investigators want to find out what effects, good and/or bad, 3 drugs called letrozole, leuprolide and everolimus will have on cancer. All of these drugs are FDA approved for the treatment of different cancers. Letrozole and leuprolide stop the body from producing estrogen, a normal hormone produced by the body. Too much estrogen may help fibrolamellar liver cancer grow. Everolimus is a drug that may block other chemicals in the body that can help cancer grow. The combination of letrozole and leuprolide plus everolimus may work well together.

Study Details

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 17, 2012
Enrollment StartJul 12, 2012
Primary CompletionJul 16, 2021
TodayJul 2, 2026
Enrollment to primary: 9.0 yearsPosted 14.0 years ago

Interventions

everolimusdrug

letrozole plus leuprolidedrug

combination of everolimus, letrozole and leuprolidedrug