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A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma

Advanced Adult Hepatocellular Carcinoma Clinical Trial

Official title:
A Phase 2, Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma (FLC)

Clinical Trial Summary

The purpose of the study is to determine whether once-daily dosing with ENMD-2076 will be a safe and effective treatment in patients with FLC. Safety will be measured by looking at the adverse events that may happen and the efficacy will look at the progression of the disease over time.

Clinical Trial Description

Primary Objective:

• To determine the 6-month progression free survival (PFS6) rate when patients with advanced fibrolamellar carcinoma (FLC) are treated with daily oral ENMD 2076

Secondary Objectives:

- To evaluate the overall response rate using RECIST v 1.1 criteria when patients with FLC are treated with daily oral ENMD 2076.

- To evaluate the median Progression Free Survival (PFS), Time to Progression (TTP), and Overall Survival (OS).

- To determine the safety of ENMD-2076 as defined by the frequency and severity of adverse events when patients with FLC are treated with daily oral ENMD-2076 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02234986
Study type Interventional
Source CASI Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date October 2015
Completion date June 30, 2018
View Details
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