Hepatocellular CarcinomaPhase 1/2NCT02400788
Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)
A Phase 1/2 study testing Resminostat and Sorafenib in people with Hepatocellular Carcinoma, run by Yakult Honsha Co., LTD at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Resminostat and Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Apr 2013to Oct 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Japan9 sites
Study site
Chiba
Study site
Ishikawa
Study site
Kanagawa
Study site
Kochi
Study site
Kyoto
Study site
Osaka
Study site
Saga
Study site
Shizuoka
Study site
Tokyo
About this study
Official title: A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Resminostat, Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResminostatDrug
SorafenibDrug
| Study group | Role | What they receive |
|---|---|---|
| Resminostat + Sorafenib | Experimental | oral administration Receives: Drug: Resminostat; Drug: Sorafenib |
| Sorafenib | Active comparator | oral administration Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability
Measured: 6 months
Phase 2 : Time To Progression (TTP)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startApr 2013
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yakult Honsha Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400788
- Sponsor's protocol ID
- YHI-1001-HCC-02
- Status last verified
- Jan 2018
- First submitted
- 10 Mar 2015
- Last updated
- 16 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT02400788
- Acronym / sponsor ID
- YHI-1001-HCC-02
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Yakult Honsha Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resminostat + Sorafenib | Experimental | Drug: Resminostat, Drug: Sorafeniboral administration |
| Sorafenib | Active comparator | Drug: Sorafeniboral administration |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resminostat | Drug | Resminostat + Sorafenib |
| Sorafenib | Drug | Resminostat + Sorafenib, Sorafenib |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Resminostat and Sorafenib in people with Hepatocellular Carcinoma, run by Yakult Honsha Co., LTD at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.