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

January 11, 2018 updated by: Yakult Honsha Co., LTD

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
      • Ishikawa, Japan
      • Kanagawa, Japan
      • Kochi, Japan
      • Kyoto, Japan
      • Osaka, Japan
      • Saga, Japan
      • Shizuoka, Japan
      • Tokyo, Japan
  • Korea, Republic of
      • Busan, Korea, Republic of
      • Daegu, Korea, Republic of
      • Seoul, Korea, Republic of

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Resminostat + Sorafenib
oral administration
Drug: Sorafenib
Drug: Resminostat
ACTIVE_COMPARATOR: Sorafenib
oral administration
Drug: Sorafenib

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yakult Honsha Co., LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (ESTIMATE)

March 27, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YHI-1001-HCC-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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