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

Yakult

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Sorafenib; Drug: Resminostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02400788

YHI-1001-HCC-02

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

Resminostat + Sorafenib

Experimental group

Description:

oral administration

Treatment:

Drug: Resminostat

Drug: Sorafenib

Sorafenib

Active Comparator group

Description:

oral administration

Treatment:

Drug: Sorafenib