Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatments resminostat, sorafenib
Phase phase 1/phase 2
Targets RAF, PDGF, VEGF, HDAC, FLT-3, KIT
Sponsor Yakult Honsha Co., LTD
Start date April 2013
End date October 2016
Trial size 150 participants
Trial identifier NCT02400788, YHI-1001-HCC-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
oral administration
resminostat
sorafenib
(Active Comparator)
oral administration
sorafenib

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Yakult Honsha Co., LTD.