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

• Sponsor: Yakult Honsha Co., LTD (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02400788
• Collaborator: (none)
• Enrollment: 179
• Locations: 12
• Arms: 2
• Duration (Months): 42
• Patients Per Site: 14.9
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Resminostat; Drug: Sorafenib	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 179 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Resminostat + Sorafenib oral administration	Drug: Resminostat; Drug: Sorafenib
Active Comparator: Sorafenib oral administration	Drug: Sorafenib

Outcome Measures

Primary Outcome Measures

1. Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability [6 months]

2. Phase 2 : Time To Progression (TTP) [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Chiba		Japan
2		Ishikawa		Japan
3		Kanagawa		Japan
4		Kochi		Japan
5		Kyoto		Japan
6		Osaka		Japan
7		Saga		Japan
8		Shizuoka		Japan
9		Tokyo		Japan
10		Busan		Korea, Republic of
11		Daegu		Korea, Republic of
12		Seoul		Korea, Republic of

Sponsors and Collaborators

• Yakult Honsha Co., LTD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yakult Honsha Co., LTD
• ClinicalTrials.gov Identifier: NCT02400788
• Other Study ID Numbers: YHI-1001-HCC-02
• First Posted: Mar 27, 2015
• Last Update Posted: Jan 16, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Sorafenib

Study Results

No Results Posted as of Jan 16, 2018