Hepatocellular CarcinomaPhase 1/2NCT01406574
Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
A Phase 1/2 study testing OPB-31121 and OPB-31121 phase2 in people with Hepatocellular Carcinoma, run by Otsuka Pharmaceutical Co., Ltd. at 2 sites in Japan.
Trial summary
The purpose of this study is: Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- OPB-31121 and OPB-31121 phase2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesJapan
- Study dates
- Jul 2011to Mar 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histopathologically or clinically confirmed diagnosis of hepatocellular carcinoma
- Patients with Child-Pugh classification A or B
- Patients unresponsive to standard therapy or for whom standard therapy is intolerable, or for whom there is no appropriate therapy
- Patients who are able to take oral medication
- Patients age 20 to 79 years (inclusive) at time of informed consent
- Patients with an ECOG performance status score of 0-2
- Patients have the eligible organ function.
Who cannot join
- Patients with a primary malignant tumor
- Patients with a history of liver transplant
- Patients with brain metastases
- Patients with a complication of uncontrolled
- Patients with a psychiatric disorder that might cause difficulty in obtaining informed consent or in conducting the trial
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Multicenter, Open-label, Non-randomized, Dose-escalation, Therapeutic Exploratory Trial to Evaluate the Safety and Efficacy of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
The purpose of this study is:
Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
- Conditions
- Hepatocellular Carcinoma
- Being tested
- OPB-31121, OPB-31121 phase2
- Keywords
- Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB-31121Drug
Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
OPB-31121 phase2Drug
Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)
| Study group | Role | What they receive |
|---|---|---|
| OPB-31121 p1 | Experimental | Phase1 step Receives: Drug: OPB-31121 |
| OPB-31121 p2 | Experimental | Phase2 step Receives: Drug: OPB-31121 phase2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects With Treatment Emergent Adverse Events
Treatment emergent adverse events observed during outcome measure time frame.
Measured: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%.
DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice
Measured: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
Secondary outcomes (1)
Best Overall Response
Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.
Measured: From first dose of study medication up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406574
- Sponsor's protocol ID
- 252-11-001
- Other IDs
- JapicCTI-111546
- Status last verified
- May 2015
- First submitted
- 28 Jul 2011
- Last updated
- 8 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Non-randomized, Dose-escalation, Therapeutic Exploratory Trial to Evaluate the Safety and Efficacy of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01406574
- Acronym / sponsor ID
- 252-11-001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Posted 8 Jun 2015
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:
Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPB-31121 p1 | Experimental | Drug: OPB-31121Phase1 step |
| OPB-31121 p2 | Experimental | Drug: OPB-31121 phase2Phase2 step |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histopathologically or clinically confirmed diagnosis of hepatocellular carcinoma
- Patients with Child-Pugh classification A or B
- Patients unresponsive to standard therapy or for whom standard therapy is intolerable, or for whom there is no appropriate therapy
- Patients who are able to take oral medication
- Patients age 20 to 79 years (inclusive) at time of informed consent
Key exclusion criteria (5 listed)
- Patients with a primary malignant tumor
- Patients with a history of liver transplant
- Patients with brain metastases
- Patients with a complication of uncontrolled
- Patients with a psychiatric disorder that might cause difficulty in obtaining informed consent or in conducting the trial
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-31121Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month) | Drug | OPB-31121 p1 |
| OPB-31121 phase2Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months) | Drug | OPB-31121 p2 |
Primary outcome
Subjects With Treatment Emergent Adverse Events
Time frame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
Treatment emergent adverse events observed during outcome measure time frame.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%. DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice
1 secondary outcome
Best Overall Response
Time frame: From first dose of study medication up to 28 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OPB-31121 and OPB-31121 phase2 in people with Hepatocellular Carcinoma, run by Otsuka Pharmaceutical Co., Ltd. at 2 sites in Japan.
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 5 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: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subjects With Treatment Emergent Adverse Events (time frame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)). 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 8 Jun 2015.