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

Y

Yakult

Status and phase

Completed
Phase 2
Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Sorafenib
Drug: Resminostat

Study type

Interventional

Funder types

Industry

Identifiers

NCT02400788
YHI-1001-HCC-02

Details and patient eligibility

About

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.

Enrollment

179 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

179 participants in 2 patient groups

Resminostat + Sorafenib
Experimental group
Description:
oral administration
Treatment:
Drug: Resminostat
Drug: Sorafenib
Sorafenib
Active Comparator group
Description:
oral administration
Treatment:
Drug: Sorafenib

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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