drugset / Trial / NCT01642186
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)
Phase 2
Completed
28 enrolled
Memorial Sloan Kettering Cancer Center
Abbott · collabDana-Farber Cancer Institute · collabFibrolamellar Cancer Foundation · collabJohns Hopkins University · collabNovartis Pharmaceuticals · collabUniversity of California, San Francisco · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2012-07-12
- Primary completion
- 2021-07-16
- Completion
- 2021-07-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 5 mg | Oral |
| Subject | Everolimus | Small molecule | 7.5 mg | Oral |
| Subject | Letrozole | Other / unclassified | — | — |
| Subject | Leuprolide | Other / unclassified | 7.5 mg | Intramuscular |