Clinical Trial: A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2, Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma (FLC)
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 Summary:
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
Sponsor: CASI Pharmaceuticals, Inc.
Current Primary Outcome: Overall Response Rate [ Time Frame: 6 months ]
Original Primary Outcome: Progression Free Survival [ Time Frame: 6 months ]
Current Secondary Outcome: Progression Free Survival (PFS6) rate [ Time Frame: 6 months ]
Original Secondary Outcome: Overall response rate [ Time Frame: 6 months ]
Information By: CASI Pharmaceuticals, Inc.
Dates:
Date Received: September 5, 2014
Date Started: October 2015
Date Completion: June 2019
Last Updated: March 19, 2016
Last Verified: March 2016
