Solid TumorPhase 1NCT02250170
Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor
A Phase 1 study testing OPB-111077 in people with Solid Tumor, run by Korea Otsuka Pharmaceutical Co., Ltd. at 3 sites in South Korea.
Trial summary
This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid tumor. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Solid Tumor
- 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
- 47 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 23 Oct 2014to 8 Mar 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically and/or cytologically confirmed advanced solid tumor
- Patients who were refractory to standard therapy or for which there are no standard treatment options available
- Age 20 to 80 years at the time of informed consent
- Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration
- Patients informed of the diagnosis of advanced solid tumor who are fully informed about the content of the study by the investigator or subinvestigator using the specified written consent form and other written explanation, and give written consent to participate in the study of their free will
- Patients who are able to take oral medication
Who cannot join
- Patients with symptomatic brain metastases
- Patients who have not recovered from any prior therapy related toxicity deemed to be clinically significant at study entry, except for the test item defined in inclusion criteria.
- Patients with active infections needing whole body therapy
- Patients with positive hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody
- Patients with positive human immunodeficiency virus (HIV) antibody
- Patients with uncontrollable cardiac diseases
Show all 11Show fewer
- Patients with uncontrollable pain by analgesic drugs
- Patients with a history of organ transplantation
- Patients who have received another IMP
- Patients who are pregnant, possibly pregnant, or lactating
- Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Asan Medical Center
Seoul
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Phase 1, Open-label, Non-Randomized, Dose Escalation Trial to Evaluate Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor
This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid tumor. Subsequently, an expansion part will further evaluate the biomarker, safety, pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.
Read the detailed description
This trial is designed to determine the safety, tolerability, maximum tolerated dose and recommended dose of OPB-111077 administered orally 4-days on and 3-days off (3 weeks/cycle) to subjects with advanced solid tumor in the dose escalation part so that biomarkers, efficacy, and others can be evaluated at the recommended dose in an expeditious manner in the expansion part. The dose escalation part employs a 3+3 escalation design as a standard dose escalation design for a small sample size.
- Conditions
- Solid Tumor
- 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
Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on \& 3 days-off (21 days=1cycle)
| Study group | Role | What they receive |
|---|---|---|
| OPB-111077 | Experimental | Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on \& 3 days-off (21 days=1cycle) Receives: Drug: OPB-111077 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants with Adverse Events
Measured: 21 days
Maximum tolerated dose
The highest dose that does not lead to discontinuation of dose escalation
Measured: 21 days
Biomarker of OPB-111077
Change from baseline on predictable biomarker specified in the protocol
Measured: 21 days
Secondary outcomes (2)
Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment
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 final study visit.
Measured: 3~18 weeks depending on tumor response
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: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study start23 Oct 2014
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Doyoun Oh, MD, Principal investigator, Seoul National University HospitalJeehyun Kim, MD, Principal investigator, Seoul National University Bundang HospitalSungbae Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250170
- Sponsor's protocol ID
- 317-KOA-1401i
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2014
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Non-Randomized, Dose Escalation Trial to Evaluate Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT02250170
- Acronym / sponsor ID
- 317-KOA-1401i
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 26 Sep 2014 (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 open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid tumor. Subsequently, an expansion part will further evaluate the biomarker, safety, pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.
Detailed description
This trial is designed to determine the safety, tolerability, maximum tolerated dose and recommended dose of OPB-111077 administered orally 4-days on and 3-days off (3 weeks/cycle) to subjects with advanced solid tumor in the dose escalation part so that biomarkers, efficacy, and others can be evaluated at the recommended dose in an expeditious manner in the expansion part. The dose escalation part employs a 3+3 escalation design as a standard dose escalation design for a small sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPB-111077 | Experimental | Drug: OPB-111077Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on \& 3 days-off (21 days=1cycle) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically and/or cytologically confirmed advanced solid tumor
- Patients who were refractory to standard therapy or for which there are no standard treatment options available
- Age 20 to 80 years at the time of informed consent
- Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration
- Patients informed of the diagnosis of advanced solid tumor who are fully informed about the content of the study by the investigator or subinvestigator using the specified written consent form and other written explanation, and give written consent to participate in the study of their free will
Key exclusion criteria (11 listed)
- Patients with symptomatic brain metastases
- Patients who have not recovered from any prior therapy related toxicity deemed to be clinically significant at study entry, except for the test item defined in inclusion criteria.
- Patients with active infections needing whole body therapy
- Patients with positive hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody
- Patients with positive human immunodeficiency virus (HIV) antibody
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-111077Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on \& 3 days-off (21 days=1cycle) | Drug | OPB-111077 |
Primary outcome
Adverse Events
Time frame: 21 days
Number of participants with Adverse Events
Maximum tolerated dose
Time frame: 21 days
The highest dose that does not lead to discontinuation of dose escalation
Biomarker of OPB-111077
Time frame: 21 days
Change from baseline on predictable biomarker specified in the protocol
2 secondary outcomes
Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment
Time frame: 3~18 weeks depending on tumor response
Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.
Time frame: 21 days
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 10 Sep 2019.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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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.
Doyoun Oh, MD principal investigator
Seoul National University Hospital
Jeehyun Kim, MD principal investigator
Seoul National University Bundang Hospital
Sungbae Kim, MD principal investigator
Asan Medical Center
3 sites 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 Solid Tumor, run by Korea Otsuka Pharmaceutical Co., Ltd. at 3 sites 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 6 inclusion and 11 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 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Adverse Events (time frame: 21 days). The study lists 3 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 10 Sep 2019.