drugset / Trial / NCT02151864

LDE225 in Patients With Advanced or Metastatic Hepatocellular Carcinoma and Child-Pugh A/B7 Cirrhosis

NCT02151864

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test the safety and determine the maximum safe dose of an experimental drug called LDE225 (hedgehog inhibitor) in people with liver cancer. We have identified hedgehog dysregulation as a novel mechanism for hepatocarcinogenesis and hepatic fibrosis/cirrhosis. Therefore, we hypothesize that the hedgehog inhibitor may be an ideal drug target for treating both hepatocellular carcinoma (HCC) and Child-Pugh A cirrhosis (CPA).

Timeline

Start
2014-07
Primary completion
2016-12
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Sonidegib Small molecule 200 mg Oral
Subject Sonidegib Small molecule 800 mg Oral