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

Phase 1

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Resminostat; Drug: Sorafenib

• Registration Number: NCT02400788
• Lead Sponsor: Yakult Honsha Co., LTD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-27
• Primary Completion: 2016-06
• Study Completion: 2016-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resminostat + Sorafenib	Resminostat	oral administration
Resminostat + Sorafenib	Sorafenib	oral administration
Sorafenib	Sorafenib	oral administration

Primary Outcome Measures

Name	Time	Method
Phase 2 : Time To Progression (TTP)	12 months
Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability	6 months