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

Yakult Honsha Co., LTD179 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

179

Conditions

Hepatocellular Carcinoma

Interventions

ResminostatDRUG

SorafenibDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (12)

Unnamed facility

Chiba, Japan

Unnamed facility

Ishikawa, Japan

Unnamed facility

Kanagawa, Japan

Unnamed facility

Kochi, Japan

Outcomes

Primary Outcomes

Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability

Time frame: 6 months

Phase 2 : Time To Progression (TTP)

Time frame: 12 months

Data from ClinicalTrials.gov

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