Advanced Hepatocellular CarcinomaPhase 1NCT01942083
A Phase I, Open Label, Non Randomized, Multicenter, Dose Escalation Clinical Study to Investigate Safety and Tolerability of OPB(Otsuka Pharmaceutical Biwa)-111077 in Subjects With Advanced HCC(Hepatocellular Carcinoma)
A Phase 1 study testing OPB-111077 in people with Advanced Hepatocellular Carcinoma, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a Phase I, open label, non randomized, multicenter study designed to investigate the safety and tolerability of escalating doses of OPB-111077 administered orally, once daily in subjects with advanced HCC. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- OPB-111077
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 May 2013to 11 Jul 2016
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically or clinically diagnosed HCC by Korean Liver Cancer Study Group (KLCSG) guidelines.
- Subject who has advanced HCC
- Documented evidence of unresponsiveness to, intolerance to, or ineligibility for sorafenib, or unavailability of appropriate sorafenib treatment
- Male or female subject, age at consent ≥20 years and ≤75 years.
- Life expectancy ≥12 weeks.
- Subjects who agree that they or their partner(s) will practice contraception during the study period and 3 months (12 weeks) after the completion of study treatment.
- Subjects informed of the diagnosis of advanced HCC who are fully informed about the content of the study by the Investigator using the written consent form, and give written consent to participate in the study of their own free will.
Who cannot join
- Past liver transplantation
- Uncontrollable hepatic encephalopathy or ascites
- Presence of brain metastases
- Clinically significant gastrointestinal bleeding in past 6 months or current active gastrointestinal bleeding.
- Primary malignancy other than HCC
- Human immunodeficiency virus (HIV) infection
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- Severe or poorly controlled complication that may affect the conduct or results of the study.
- Use of Interferon preparation within 4 weeks (28 days) before start of study treatment in the present study.
- Pregnant, nursing, or possibly pregnant women, or women desiring to become pregnant during the study period
- Other cases judged by the Investigator to be ineligible for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase I, open label, non randomized, multicenter study designed to investigate the safety and tolerability of escalating doses of OPB-111077 administered orally, once daily in subjects with advanced HCC.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- OPB-111077
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB-111077Drug
| Study group | Role | What they receive |
|---|---|---|
| OPB-111077 | Experimental | orally, once daily Receives: Drug: OPB-111077 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of OPB-111077
Number of participants with adverse events as assessed by CTCAE v4.0
Measured: Within the first cycle [24 days]
To investigate the maximum tolerated dose (MTD) of OPB-111077
- The highest dose that does not lead to discontinuation of dose escalation is defined as the MTD.
Measured: Within the first cycle [24 days]
Secondary outcomes (3)
Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.
The following PK parameters (Cmax (maximum observed concentration), AUC(area uder the concentration time curve from zero), tmax (Time to maximum plasma concentration), etc.) will be determined using a non-compartmental methods.
Measured: Within the first cycle [24 days]
Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1
Assessment will be conducted at Screening, end of Cycle 1, end of Cycle 2, end of every 2 cycles thereafter, at the Early Termination (discontinuation) Visit.
Measured: Approximately 3-18 weeks depending on tumor response
Biomarker of OPB-111077
Change from baseline on predictable biomarker specified in the protocol
Measured: Within the first cycle [24 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study start29 May 2013
- Primary completion1 Jun 2016
- Study completion11 Jul 2016
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- Dose escalation study
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942083
- Sponsor's protocol ID
- 317-12-001
- Other IDs
- There is no secondary ID.
- Status last verified
- May 2017
- First submitted
- 26 Jun 2013
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Non Randomized, Multicenter, Dose Escalation Clinical Study to Investigate Safety and Tolerability of OPB(Otsuka Pharmaceutical Biwa)-111077 in Subjects With Advanced HCC(Hepatocellular Carcinoma)
- ClinicalTrials.gov ID
- NCT01942083
- Acronym / sponsor ID
- 317-12-001
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2013 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 11 Jul 2016 (actual)
- First posted
- 13 Sep 2013 (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.
This is a Phase I, open label, non randomized, multicenter study designed to investigate the safety and tolerability of escalating doses of OPB-111077 administered orally, once daily in subjects with advanced HCC.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| OPB-111077 | Experimental | Drug: OPB-111077orally, once daily |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histopathologically or clinically diagnosed HCC by Korean Liver Cancer Study Group (KLCSG) guidelines.
- Subject who has advanced HCC
- Documented evidence of unresponsiveness to, intolerance to, or ineligibility for sorafenib, or unavailability of appropriate sorafenib treatment
- Male or female subject, age at consent ≥20 years and ≤75 years.
- Life expectancy ≥12 weeks.
Key exclusion criteria (10 listed)
- Past liver transplantation
- Uncontrollable hepatic encephalopathy or ascites
- Presence of brain metastases
- Clinically significant gastrointestinal bleeding in past 6 months or current active gastrointestinal bleeding.
- Primary malignancy other than HCC
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 |
|---|---|---|
| OPB-111077 | Drug | OPB-111077 |
Primary outcome
Safety of OPB-111077
Time frame: Within the first cycle [24 days]
Number of participants with adverse events as assessed by CTCAE v4.0
To investigate the maximum tolerated dose (MTD) of OPB-111077
Time frame: Within the first cycle [24 days]
• The highest dose that does not lead to discontinuation of dose escalation is defined as the MTD.
3 secondary outcomes
Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.
Time frame: Within the first cycle [24 days]
Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1
Time frame: Approximately 3-18 weeks depending on tumor response
Biomarker of OPB-111077
Time frame: Within the first cycle [24 days]
Results and safety
The study was stopped early (reason given: Company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPB-111077 in people with Advanced Hepatocellular Carcinoma, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. 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: stopped early, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 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.
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 was stopped early (reason given: Company decision). Results are not available in the source record.
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?
Safety of OPB-111077 (time frame: Within the first cycle [24 days]). 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 9 May 2017.