Solid TumorPhase 1NCT00657176
An Open-Label Phase-1 Study of OPB-31121 in Patients With Advanced Solid Tumors
A Phase 1 study testing OPB-31121 in people with Solid Tumor, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is an open-label, non-randomized, single-center, dose-escalation study in patients with advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned for the study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- OPB-31121
- Type of treatment
- Pill or oral medicine
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Jun 2009
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed solid tumor refractory to standard therapy or for which there is no standard therapy
- Age: more than 19 years
- ECOG performance status: less than 2
- Life expectancy of longer than 3 months
- Adequate vital organ function as follows:
- Bone marrow function
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- neutrophils: more than 1,500 per microliter
- platelets: more than 75,000 per microliter
- hemoglobin: more than 10.0g per deciliter
- Hepatic function
- AST and ALT: less than 2.5 x institutional upper limit normal
- serum total bilirubin: less than 2.5 x institutional ULN
- Renal function
- Serum creatinine: less than 1.5 x institutional ULN
- Capable of swallowing OPB-31121 tablets
- Ability to understand and willingness to sign written informed consent document for participation in the trial and for analysis of genotypes CYP2C9 and NAT2
- No chemotherapy, radiotherapy, surgery, or immunotherapy within 4 weeks prior to study entry and recovered from any prior toxicity
Who cannot join
- Symptomatic CNS metastasis
- Uncontrolled concurrent illness, including active infection, heart failure, angina pectoris, and cardiac arrhythmia
- Psychiatric illness that would limit compliance with study requirements
- Pregnant or breast-feeding women and women of childbearing potential who cannot or will not use effective contraceptive measures
- Administration of another investigational agent within 6 months prior to study entry
- Use of CYP3A4 and CYP2C9 inducers, inhibitors, or substrates, and CYP2B6, CYP2C8 and CYP2D6 substrates
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- Hyperlipidemia:
- Total cholesterol:more than 300 milligram per deciliter or Triglycerides:
- more than 2.5 x institutional ULN
- Abnormal thyroid function: Hypothyroidism or hyperthyroidism of grade 2 or higher (graded according to the NCI-CTCAE)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Hanna Lee, Bachelor, +82-2-2072-0603, life1025@naver.com
Yung-Jue Bang, PhD
About this study
Official title: A Phase 1, Open-Label, Non-Randomized Study of OPB-31121 in Patients With Advanced Solid Tumors
This is an open-label, non-randomized, single-center, dose-escalation study in patients with advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned for the study. In this study, OPB-31121's potential for toxic effects will be evaluated in patients with advanced solid tumors to evaluate the recommended dose for use in subsequent studies. The pharmacokinetics and antitumor effect of the compound will also be investigated.
- Conditions
- Solid Tumor
- Being tested
- OPB-31121
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB-31121Drug
- 100mg tablet
- oral administration, Qd
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: Cycle 1
Secondary outcomes (3)
Safety and dose-limiting toxicity
Measured: Duration of Study
Pharmacokinetics
Measured: Cycle 1
Antitumor effect
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009 (estimated)
- Study completionJun 2009 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yung-Jue Bang, PhD, Principal investigator, Division of Hematology and Medical Oncology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657176
- Sponsor's protocol ID
- 252-KOA-0701
- Status last verified
- Apr 2008
- First submitted
- 9 Apr 2008
- Last updated
- 18 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Non-Randomized Study of OPB-31121 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00657176
- Acronym / sponsor ID
- 252-KOA-0701
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 14 Apr 2008 (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 an open-label, non-randomized, single-center, dose-escalation study in patients with advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned for the study. In this study, OPB-31121's potential for toxic effects will be evaluated in patients with advanced solid tumors to evaluate the recommended dose for use in subsequent studies. The pharmacokinetics and antitumor effect of the compound will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed solid tumor refractory to standard therapy or for which there is no standard therapy
- Age: more than 19 years
- ECOG performance status: less than 2
- Life expectancy of longer than 3 months
- Adequate vital organ function as follows:
Key exclusion criteria (10 listed)
- Symptomatic CNS metastasis
- Uncontrolled concurrent illness, including active infection, heart failure, angina pectoris, and cardiac arrhythmia
- Psychiatric illness that would limit compliance with study requirements
- Pregnant or breast-feeding women and women of childbearing potential who cannot or will not use effective contraceptive measures
- Administration of another investigational agent within 6 months prior to study entry
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-31121* 100mg tablet * oral administration, Qd | Drug | – |
Primary outcome
Maximum tolerated dose
Time frame: Cycle 1
3 secondary outcomes
Safety and dose-limiting toxicity
Time frame: Duration of Study
Pharmacokinetics
Time frame: Cycle 1
Antitumor effect
Time frame: Duration of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2008.
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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.
Yung-Jue Bang, PhD principal investigator
Division of Hematology and Medical Oncology, Seoul National University Hospital
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-31121 in people with Solid Tumor, 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 17 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: status not confirmed, as of the sponsor's last update on 18 Apr 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yung-Jue Bang, PhD (82-2-2072-2390, bangyj@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: Cycle 1). 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 18 Apr 2008.