Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess efficacy and safety in combination of resminostat and sorafenib in Asian patients with advanced HCC previously untreated with systemic chemotherapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yakult Honsha Co., LTD
• Treatments: Niacinamide; Sorafenib

Criteria

Main Inclusion Criteria:

• Patients with advanced or metastatic hepatocellular carcinoma

• Patients with ECOG PS of 0-1

• Patients who can be treated with oral medications and have no gastrointestinal function disorder which is considered to affect the absorption of medications

Main Exclusion Criteria:

• Patients with a history of treatment with HDAC inhibitors

• Pregnant women and lactating mothers

• Patients with brain metastases or suspected brain metastases based on the clinical symptoms