NCT02234986

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: CASI Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Adult Hepatocellular Carcinoma
• Advanced Fibrolamellar Carcinoma

Interventions

Type	Name	Description
DRUG	ENMD-2076	250 mg oral dose, once daily (QD) for 28 day cycles

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2014-09-09
• Last updated: 2025-04-18
• Results posted: 2025-04-18

Locations

5 sites across 1 country: United States