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

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Trial Identification

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

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

Study ID: NCT02234986

Conditions

Advanced Adult Hepatocellular Carcinoma

Advanced Fibrolamellar Carcinoma

Interventions

ENMD-2076

Study Description

Brief 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.

Detailed 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