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

Phase 2 Completed 35 enrolled CASI pharmaceuticals, Inc.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2015-10
Primary completion: 2018-06-30
Completion: 2018-06-30

Outcome

Met primary endpoint

release “today announced that its Phase 2 trial of ENMD-2076 in fibrolamellar carcinoma (FLC) has met its Stage 1 endpoint of objective response for non-futility” issuerdirect.com ↗

Publications

Abou-Alfa GK, Mayer R, Venook AP, O'Neill AF, Beg MS, LaQuaglia M, Kingham PT, Kobos R, Basturk O, Brennan C, Yopp A, Harding JJ, Leong S, Crown J, Hoti E, Leonard G, Ly M, Bradley M, Valentino E, Markowitz D, Zukiwski A, Ren K, Gordan JD. Phase II Multicenter, Open-Label Study of Oral ENMD-2076 for the Treatment of Patients with Advanced Fibrolamellar Carcinoma. Oncologist. 2020 Dec;25(12):e1837-e1845. doi: 10.1634/theoncologist.2020-0093. Epub 2020 Mar 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ENMD-2076	Small molecule	250 mg	Oral