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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chiba, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

resminostat

Drug

Sorafenib

Drug

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

Sponsors and collaborators

Lead sponsor

Yakult Honsha Co., LTD

Industry

Registry information

Official study title

A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Mar 27, 2015
Registry last updated: Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed