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

NCT02234986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-04-18

Study results available
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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.

Conditions

  • Advanced Adult Hepatocellular Carcinoma
  • Advanced Fibrolamellar Carcinoma

Interventions

DRUG

ENMD-2076

250 mg oral dose, once daily (QD) for 28 day cycles

Sponsors & Collaborators

  • CASI Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Ken Ren, PhD · CASI Pharmaceuticals, Inc.

  • Ghassan Abou-Alfa, MD · MSKCC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02234986 on ClinicalTrials.gov