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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02400788
Enrollment
179
Registered
2015-03-27
Start date
2013-04-30
Completion date
2016-10-31
Last updated
2018-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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.

Interventions

DRUGResminostat
DRUGSorafenib

Sponsors

Yakult Honsha Co., LTD
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability6 months
Phase 2 : Time To Progression (TTP)12 months

Countries

Japan, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026