NCT02939807

A Phase II Study of ABC294640 as Monotherapy in Patients With Advanced Hepatocellular Carcinoma

A Phase II Study of ABC294640 in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Sorafenib

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II study of single agent ABC294640. Patients with advanced hepatocellular carcinoma (HCC) who have experienced tumor progression or unacceptable toxicity on single agent sorafenib will receive ABC294640 500 mg by mouth twice a day continuously. Patients will continue on study drug until the development of progressive disease per modified RECIST, intolerable toxicity, withdrawal of patient consent or other event as outlined in patient discontinuation.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	ABC294640	ABC294640 500 mg orally twice daily (approximately 12 hours apart) continuously. ABC294640 will be dosed under fasting conditions (at least 1 hour before or 2 hours after eating). A cycle is defined as 28 days.

Timeline

• Start date: 2019-09-30
• Primary completion: 2023-09-30
• Completion: 2024-01-30
• First posted: 2016-10-20
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study