NCT02400788

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2013

Typical duration for phase_1 hepatocellular-carcinoma

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

3.2 years

First QC Date

March 10, 2015

Last Update Submit

January 11, 2018

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability

    6 months

  • Phase 2 : Time To Progression (TTP)

    12 months

Study Arms (2)

Resminostat + Sorafenib

EXPERIMENTAL

oral administration

Drug: ResminostatDrug: Sorafenib

Sorafenib

ACTIVE COMPARATOR

oral administration

Drug: Sorafenib

Interventions

ResminostatDRUG
Resminostat + Sorafenib
SorafenibDRUG
Resminostat + SorafenibSorafenib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Ishikawa, Japan

Location

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Kochi, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Saga, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

resminostatSorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 27, 2015

Study Start

April 1, 2013

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

KR(3)JP(9)