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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Resminostat
Sorafenib
Sponsored by
Yakult Honsha Co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resminostat + Sorafenib

Sorafenib

Arm Description

oral administration

oral administration

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 10, 2015
Last Updated
January 11, 2018
Sponsor
Yakult Honsha Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT02400788
Brief Title
Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)
Official Title
A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yakult Honsha Co., LTD

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resminostat + Sorafenib
Arm Type
Experimental
Arm Description
oral administration
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Resminostat
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Primary Outcome Measure Information:
Title
Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability
Time Frame
6 months
Title
Phase 2 : Time To Progression (TTP)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Chiba
Country
Japan
City
Ishikawa
Country
Japan
City
Kanagawa
Country
Japan
City
Kochi
Country
Japan
City
Kyoto
Country
Japan
City
Osaka
Country
Japan
City
Saga
Country
Japan
City
Shizuoka
Country
Japan
City
Tokyo
Country
Japan
City
Busan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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