LDE225 in Patients With Advanced or Metastatic Hepatocellular Carcinoma and Child-Pugh A/B7 Cirrhosis
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|ClinicalTrials.gov Identifier: NCT02151864|
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Cirrhosis||Drug: LDE225||Phase 1|
This is an open-label, single institution, Phase I, 3+3 dose escalation study of LDE225 in patients with advanced or metastatic hepatocellular carcinoma and Child-Pugh A Cirrhosis who are intolerant to sorafenib. The investigational treatment cycle (21 days) will consist of daily oral LDE225.
Dose escalation will be performed in serial patient cohorts. Up to six patients can be studied at each dose level. Safety and clinical data will be tabulated and the decision to open the next cohort level will be the responsibility of the principal investigator. Dose escalation will be based on the dose-limiting toxicities encountered through Day 42 of investigational treatment.
Patients will be dosed on a flat scale of daily dosing of LDE225 prescribed by the dose cohort.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Study of Single Agent LDE225, an Oral Hedgehog Inhibitor, as Second-Line Therapy in Patients With Advanced or Metastatic Hepatocellular Carcinoma and Child-Pugh A/B7 Cirrhosis|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||September 2017|
LDE225 200mg-800mg oral daily
LDE225 will be administered orally, on a continuous once daily dosing schedule at a dose determined by the cohort the patient is enrolled in until progression or unacceptable toxicity develops
Other Name: hedgehog inhibitor
- Rate of dose limiting toxicities [ Time Frame: occurring within 42 days of investigational treatment ]A dose limiting toxicity is a clinically significant adverse event (AE) occurring within 42 days of investigational treatment that is considered by the investigator to be possibly, probably, or definitely related to LDE225.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151864
|United States, California|
|UCSD Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Jason K. Sicklick, MD||University of California Medical Center|